IH-1000 001100Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07611969205493), received between Apr 22, 2021 and Apr 28, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION DURING PATIENT ANTIBODY SCREENING WHEN A SAMPLE WAS TESTED IN THE SAME BATCH AS ANOTHER SAMPLE FROM A PATIENT RECEIVING ANTI-CD38 THERAPY. - ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT SAMPLE (B)(6) BELONGS TO THE PATIENT WITH ANTI-CD38. - DAILY JOURNAL REVIEW: THE SAMPLE SHOWED IN ANTIBODY SCREENING TEST STRONG REACTIONS INTERPRETED 1+. THE OTHER SAMPLE (B)(6) SHOWED IN ANTIBODY SCREENING TEST WEAKER REACTIONS INTERPRETED 1+ AS WELL. - TRACES FILES ANALYSIS: REVIEW OF THE COMPLETE WORKFLOW SHOWS THAT THE PIPETTING NEEDLE SEQUENTIALLY ACCESSED TUBES (B)(6), THEN AGAIN (B)(6), FOLLOWED BY (B)(6). GIVEN THIS SEQUENCE, THERE IS A CREDIBLE RISK OF CARRY-] OVER. SPECIFICALLY, SAMPLE (B)(6) MAY HAVE BEEN CONTAMINATED DURING THE ANTIBODY SCREENING PROCESS AFTER THE NEEDLE PREVIOUSLY ASPIRATED MATERIAL FROM SAMPLE (B)(6) DURING THE FORWARD GROUPING TEST. THIS SEQUENCE CONSTITUTES A PLAUSIBLE TECHNICAL EXPLANATION FOR THE OBSERVED FINDINGS AND SHOULD BE CONSIDERED A LIKELY CONTRIBUTING FACTOR IN THE INVESTIGATION. RESOLUTION: THERE IS THE "FAQ ANTI-CD38 SAMPLES TESTING ON INSTRUMENTS" DOCUMENT AVAILABLE IN THE IH-AREA. IT PROVIDES EXPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021759 ↗
• MalfunctionMar 24, 2026False Positive Result

  IH-1000: FALSE POSITIVE ANTI-B AND CONTROL ON IH-CARD ABO/D(DVI-)+REV A1, B (REF. (B)(4), LOT 9539020, EXPIRY 1/25/2027). TUBE TESTING WAS CONSISTENT WITH THE PATIENT BEING A POSITIVE. TRACE ANALYSIS SHOWS PIPETTOR WASHING STEPS COMPLETED AS EXPECTED. NO ERRORS NOTED DURING THESE STEPS. CARD PIPETTING ORDER PERFORMED IN WELLS 4, 3, 2, AND 1, WHICH DOES NOT CONCUR WITH INTER-WELL CARRYOVER PLAUSIBILITY. THE SAMPLE PROCESSED IMMEDIATELY PRIOR (26AB-03B028) SHOWED STRONG (++++) O POSITIVE REVERSE REACTIONS. GIVEN THE STRENGTH OF THIS REACTION, THERE IS A PLAUSIBLE RISK OF INTER-SAMPLE CARRY-OVER, PARTICULARLY IF THE PREVIOUS SAMPLE HAD A HIGH-TITER ANTI-A. THE SIMILAR UNEXPECTED AGGLUTINATION PATTERN OBSERVED IN BOTH THE CONTROL WELL AND ANTI-B WELL SUPPORTS THIS HYPOTHESIS. CONCLUSION: TRACE ANALYSIS SHOWS PIPETTOR WASHING STEPS COMPLETED AS EXPECTED. NO ERRORS NOTED DURING THESE STEPS. CARD PIPETTING ORDER PERFORMED IN WELLS 4, 3, 2, AND 1, WHICH DOES NOT CONCUR WITH INTER-WELL CARRYOVER PLAUSIBILITY. THE SAMPLE PROCESSED IMMEDIATELY PRIOR (26AB-03B028) SHOWED STRONG (++++) O POSITIVE REVERSE REACTIONS. GIVEN THE STRENGTH OF THIS REACTION, THERE IS A PLAUSIBLE RISK OF INTER-SAMPLE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675246 ↗
• MalfunctionFeb 17, 2026False Negative Result

  THE CUSTOMER REPORTED THAT DURING THEIR PERFORMANCE QUALIFICATION VALIDATION FOR THEIR NEW IH-1000 SN (B)(6), FALSE NEGATIVE TEST RESULTS WERE OBSERVED. DURING VALIDATION, 6 SAMPLES TESTED POSITIVE WITH THEIR OLD IH-1000S (PRODUCTION INSTRUMENTS) BUT TESTED NEGATIVE ON THE IH-1000 SN (B)(6). THE RESULTS ON THE NEW IH-1000 SN (B)(6) WERE AUTO-VERIFIED. THE SAMPLES WERE TESTED ON (B)(6) 2026 (THIS REPORT) AND (B)(6) (PLEASE ALSO SEE REPORT 9610824-2026-00007). THE CUSTOMER STATED QC PASSED PRIOR TO RUNNING THE VALIDATION SAMPLES. SHE ALSO REPORTED THE REACTIONS WERE 3+ ON THE OLD IH-1000S. ACCORDING TO HER, THE SAMPLES WERE TESTED WITHIN 24 HOURS OF BEING TESTED ON THE OLD IH-1000S VS. THE NEW IH-1000. INVESTIGATION: NO OTHER COMPLAINTS HAVE BEEN RECORDED FOR THE MATERIALS USED BY THE CUSTOMER: IH-CELL POOL, LOT 9550011, EXP. 09.02.2026, AND IH-CARD AHG ANTI-IGG, LOT 9530010, EXP. 21.11.2026. BASED ON THE RECORDS, WE CAN CONFIRM THAT NO PRODUCT RELATED QUALITY ISSUE IS DIRECTLY INVOLVED IN THE REPORTED CASE. BASED ON THE TRACEFILES ANALYSIS FOR IH-1000 SN (B)(6) AND IH-1000 SN (B)(6), USING OUR IH-1000 ANALYSIS TOOLS ON THE REPORTED SAMPLES (SAMPLE (B)(6) AND SAMPLE (B)(6)), WE CONFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362190 ↗
• MalfunctionFeb 17, 2026False Negative Result

  THE CUSTOMER REPORTED THAT DURING THEIR PERFORMANCE QUALIFICATION VALIDATION FOR THEIR NEW IH-1000 SN (B)(6)., FALSE NEGATIVE TEST RESULTS WERE OBSERVED. DURING VALIDATION, 6 SAMPLES TESTED POSITIVE WITH THEIR OLD IH-1000S (PRODUCTION INSTRUMENTS) BUT TESTED NEGATIVE ON THE IH-1000 SN 6300008. THE RESULTS ON THE NEW IH-1000 SN (B)(6) WERE AUTO-VERIFIED. THE SAMPLES WERE TESTED ON (B)(6) 2026 (PLEASE SEE ALSO REPORT 9610824-2026-00006). AND (B)(6) 2026 (THIS REPORT). THE CUSTOMER STATED QC PASSED PRIOR TO RUNNING THE VALIDATION SAMPLES. SHE ALSO REPORTED THE REACTIONS WERE 3+ ON THE OLD IH-1000S. ACCORDING TO HER, THE SAMPLES WERE TESTED WITHIN 24 HOURS OF BEING TESTED ON THE OLD IH-1000S VS. THE NEW IH-1000. THE INVESTIGATION OF THIS CASE IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362189 ↗
• MalfunctionFeb 3, 2026False Negative Result

  THE CUSTOMER REPORTED INCORRECT INTERPRETATION ON ANTIBODY DETECTION RESULTS WHEN USING IH-CELL I-II-III ON THEIR IH-1000 INSTRUMENT. VISUALLY, CELLS 1 AND 2 OF IH-CELL I-II-III APPEARED WEAKLY POSITIVE, CELL 2 WAS INTERPRETED AS NEGATIVE BY THE INSTRUMENT. THE AFFECTED INSTRUMENT WAS CHECKED. ACCORDING TO THE INVESTIGATION PERFORMED, THERE IS NO ERROR DURING THE PROCESSING OF THE TEST AND NO PIPETTING ERRORS WERE RECORDED, THE VOLUMES OF PLASMA AND REAGENT RED BLOOD CELLS WERE WITHIN THE SPECIFICATIONS. THE GEL CARD IMAGE DOES NOT APPEAR MISALIGNED, THEREFORE A GRIPPER POSITIONING OR ADJUSTMENT ISSUE CAN BE RULED OUT. VISUALLY, THE REACTION APPEARS WEAKLY POSITIVE, HOWEVER THE INSTRUMENT INTERPRETED THE CELL 2 AS NEGATIVE. BASED ON THE AVAILABLE DATA, THIS DOES NOT APPEAR TO BE A REAGENT-RELATED ISSUE. THE FINDINGS ARE MORE CONSISTENT WITH AN IMAGE ANALYSIS / ALGORITHM INTERPRETATION DISCREPANCY. THE RAW GEL CARD IMAGE HAS BEEN SHARED WITH OUR R&D DEPARTMENT AND THEY CONFIRMED WITH AN IMAGE ANALYSIS THAT THE FALSE NEGATIVE RESULT IS DUE TO THE ATYPICAL SHAPE OF THE REACTION. TWO POINTS ARE LEADING TO THE FALSE NEGATIVE INTERPRETATION: PACKED RED CELLS DOING LIKE A THICK LINE, ZONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245755 ↗
• MalfunctionDec 1, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE IH-1000'S UPS (EXTERNAL BACKUP BATTERY). SUPPOSEDLY THERE WERE POWER ISSUES ON THE CUSTOMER'S SITE. NO ONE WAS HARMED AND THERE NO PROPERTY DAMAGE OCCURRED. A FIELD SERVICE ENGINEER WAS ON SITE AND CHECKED THE AFFECTED INSTRUMENT. HE REPLACED THE UPS AND VERIFIED THAT THE INSTRUMENT IS RUNNING AT MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678905 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE BACK OF HER IH-1000 INSTRUMENT. NOBODY WAS HARMED BY THE SMELL. A FIELD SERVICE ENGINEER WAS ON SITE AND CHECKED THE AFFECTED INSTRUMENT. HE CHECKED ALL OF THE TRANSPORT ARM ELECTRONIC BOARDS AND CABLES, BOTH INTERNAL PCS, AND PUMP ASSEMBLY BUT WAS UNABLE TO FIND ANY TRACE OF BURNT COMPONENTS. AT A CERTAIN POINT, HE ALSO NOTICED A BURNING SMELL. THE FAILURE WAS TRACED TO THE ELECTRONIC BOARDS. REPLACEMENT OF THE TRANSPORT ARM APPLICATIVE BOARD AND ASSOCIATED AXIS BOARDS RESOLVED THE ISSUES. THE INSTRUMENT WAS RETURNED TO THE CUSTOMER OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. NO REPORTS OF ANY SMELLS WERE REPORTED SINCE THE COMPLETION OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182142 ↗
• MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Arcing; Sparking; Electrical /Electronic Property Problem; Arcing; Sparking

  THE CUSTOMER REPORTED THAT THE IH-1000 INSTRUMENT ON-SITE SHOWED A RED ALARM MESSAGE STATING "IONISER FAILURE" AND THAT HE OBSERVED SPARKING ON THE INSTRUMENT PIERCER. THE CUSTOMER WAS ADVISED TO SHUT OFF THE INSTRUMENT UNTIL ONE OF OUR FIELD SERVICE ENGINEERS CHECKED THE INSTRUMENT. NO HARM OCCURRED. THE ISSUE WAS SOLVED BY CLEANING OFF THE DEBRIS ON THE PIERCER PINS. THE IH-1000 INSTRUMENT WAS RETURNED INTO WORKING CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907219 ↗
• MalfunctionApr 22, 2025Arcing of Electrodes; Arcing; Arcing of Electrodes; Arcing

  THE CUSTOMER REPORTED THAT HE OBSERVED BLUE SPARKS ON HIS IH-1000 INSTRUMENT. THE SPARKS CAME FROM THE PIERCING MODULE AND LASTED ABOUT 4-5 MINUTES, AND THEN STOPPED. PREVIOUSLY, THE INSTRUMENT RAN ALL NIGHT WITH NO ISSUES.THE CUSTOMER WAS ADVISED TO SHUT DOWN THE INSTRUMENT AND TOGGLE OFF THE MAIN POWER SWITCH AND NOT TO USE THE INSTRUMENT UNTIL ONE OF OUR FIELD SERVICE ENGINEERS CLEARS THE INSTRUMENT FOR USE. NOBODY WAS HARMED BY THE SPARKING. THE FIELD SERVICE ENGINEER WAS ON-SITE AND CHECKED THE INSTRUMENT, SPECIFICALLY THE TIGHTENING THE SCREWS AND THE POSITION OF THE IONOZER, AND THE IONISATION FUNCTION. HE ALSO PERFORMED CARD PIERCING CYCLES WIT IONIZATION. ON SITE, THE FIELD SERVICE ENGINEER FOUND PIECES OF PAPER THAT WERE STUCK ON THE IONIZATION PINS. AFTER CLEANING UP, TESTS WERE MADE BUT THE ISSUE IS NOT REPRODUCIBLE AS IT WAS RANDOM AND APPARENTLY SOLVED WITH THE CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880139 ↗
• MalfunctionMar 28, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT ANTI-E ANTIBODIES WERE NOT DETECTED WHEN HE TESTED WITH IH-CELL I-II-III ON THE IH-CARD AHG ANTI-IGG ON TWO DIFFERENT IH-1000 INSTRUMENTS (SEE ALSO REPORT 9610824-2025-00012). THE CUSTOMER STATED THAT ANTI-E ANTIBODIES WERE DETECTED WITH IMMUCOR REAGENTS BUT NOT THE IH-CARD. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYSED. THE INCUBATION PERIOD PROCEEDED AS ANTICIPATED, WITH A CENTRIFUGE WAITING TIME OF 6 MINUTES AND 6 SECONDS, WHICH REMAINS WITHIN THE DEVICE SPECIFICATIONS. GIVEN THAT ANTI-E ANTIBODIES ARE TYPICALLY OF THE IGM TYPE AND REACT MORE EFFECTIVELY AT LOWER TEMPERATURES, ONE MIGHT EXPECT A REACTION DUE TO THE WAITING TIME AT ROOM TEMPERATURE IN THE CENTRIFUGE. HOWEVER, NO SUCH REACTION WAS OBSERVED. THERE WERE NO MALFUFUNCTIONS DURING THE OTHER STEPS OF SAMPLE PROCESSING ON THE DEVICE. THE INSTRUMENT WORKED WITH NO ISSUES. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF THE AFFECTED LOTS OF IH-CELL I-II-III AND IH-CARD AHG ANTI-IGG. FIVE DIFFERENT E-ANTIGEN POSITIVE DONOR CELLS WERE TITRATED WITH A KNOWN ANTI-E SERUM IN THE IH-CARD AHG ANTI-IGG. ALL FIVE DONOR CELLS REACTED POSITIVELY UP TO THE TITER LEVEL OF 1:8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718591 ↗
• MalfunctionMar 28, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT ANTI-E ANTIBODIES WERE NOT DETECTED WHEN HE TESTED WITH IH-CELL I-II-III ON THE IH-CARD AHG ANTI-IGG ON TWO DIFFERENT IH-1000 INSTRUMENTS (SEE ALSO REPORT 9610824-2025-00012). THE CUSTOMER STATED THAT ANTI-E ANTIBODIES WERE DETECTED WITH IMMUCOR REAGENTS BUT NOT THE IH-CARD. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYSED. THE INCUBATION PERIOD PROCEEDED AS ANTICIPATED, WITH A CENTRIFUGE WAITING TIME OF 6 MINUTES AND 6 SECONDS, WHICH REMAINS WITHIN THE DEVICE SPECIFICATIONS. GIVEN THAT ANTI-E ANTIBODIES ARE TYPICALLY OF THE IGM TYPE AND REACT MORE EFFECTIVELY AT LOWER TEMPERATURES, ONE MIGHT EXPECT A REACTION DUE TO THE WAITING TIME AT ROOM TEMPERATURE IN THE CENTRIFUGE. HOWEVER, NO SUCH REACTION WAS OBSERVED. THERE WERE NO MALFUFUNCTIONS DURING THE OTHER STEPS OF SAMPLE PROCESSING ON THE DEVICE. THE INSTRUMENT WORKED WITH NO ISSUES. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF THE AFFECTED LOTS OF IH-CELL I-II-III AND IH-CARD AHG ANTI-IGG. FIVE DIFFERENT E-ANTIGEN POSITIVE DONOR CELLS WERE TITRATED WITH A KNOWN ANTI-E SERUM IN THE IH-CARD AHG ANTI-IGG. ALL FIVE DONOR CELLS REACTED POSITIVELY UP TO THE TITER LEVEL OF 1:8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718586 ↗
• MalfunctionFeb 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT HIS IH-1000 INSTRUMENT SUDDENLY SHUT OFF AND NO LIGHT WAS SHOWING ON THE UPS POWER SUPPLY. OUR FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT AND UPON CLOSER INSPECTION, NOTICED A BURNING SMELL COMING FROM THE UPS. THE BURNING SMELL DISSOLVED AS SOON AS THE INSTRUMENT WAS UNPLUGGED. NO USER OR CUSTOMER WAS HARMED OR INJURED. THE FIELD SERVICE ENGINEER REPLACED THE INSTRUMENT'S POWER SUPPLY (UPS). HE PERFORMED POST-SERVICE VERIFICATION IN ORDER TO VALIDATE THAT THE INSTRUMENT WAS FUNCTIONING WITHIN MANUFACTURER'S SPECIFICATIONS. THE INSTRUMENT HAS BEEN VALIDATED TO BE IN WORKING CONDITIONS AND NO INCIDENTS HAVE BEEN REPORTED BY THE CUSTOMER SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394839 ↗
• MalfunctionFeb 12, 2025Arcing of Electrodes; Arcing of Electrodes

  ONE OF OUR FIELD SERVICE ENGINEER WAS AT A CUSTOMER SITE AND REPORTED AN ISSUE WITH THE IONIZER OF THE CUSTOMER'S IH-1000 INSTRUMENT. DURING A WORK INTERVENTION THE FIELD SERVICE ENGINEER OBSERVED AN ARCING BETWEEN THE CONNECTED PIERCER'S PINS. NOBODY WAS INJURED OR HARMED BY THE ARCING. OUR FIELD SERVICE ENGINEER CLEANED ALL PINS AND THE PLASTIC ENCLOSURE OF THE IONIZER AND NO ARCING WAS OBSERVED AFTERWARDS. CLEANING OF THE MODULE AND ASSOCIATED COMPONENTS SOLVED THE ISSUE. THIS COMPLAINT WAS INITIALLY ASSESSED AS NOT TO MEET FDA'S REPORTING CRITERIA: THE INCIDENT OCCURRED DURING A SERVICE INTERVENTION BY ONE OF OUR FIELD SERVICE ENGINEERS AND NO ACTUAL HARM AND/OR NO DISCREPANCIES IN TEST RESULTS OCCURRED. IT WAS LATER DECIDED THAT THIS ASSESSMENT IS A CASE OF DOUBT AND THEREFORE THIS REPORT IS BEING SUBMITTED. BECAUSE OF THE INITIAL ASSESSMENT, WE MISSED FDA'S REPORTING DEADLINE AND APOLOGIZE PROFUSELY FOR IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363765 ↗
• MalfunctionNov 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEY HEARD A NOISE AND NOTICED A BURNING SMELL AND THE IH-1000 SHUTDOWN. THE CUSTOMER SAW THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS THE CAUSE OF THE SMELL. THE CUSTOMER STATED THAT SHE DID NOT SEE ANY FIRE BUT ONLY NOTICED THE SMELL AND THAT NOBODY WAS HURT. THE CUSTOMER WAS ADVISED NOT TO USE THE INSTRUMENT AND NOT TO PLUG ANYTHING BEFORE OUR FIELD SERVICE ENGINEER IS ONSITE. A FIELD SERVICE ENGINEER CAME TO THE CUSTOMER'S SITE AND DISCONNECTED THE INSTRUMENT FROM POWER (WALL SOCKET). THE FIELD SERVICE ENGINEER VERIFIED THE ERRORS AND REPLACED THE FAULTY UPS DEVICES. THE INSTRUMENT WAS CHECKED FOR PROPER FUNCTIONALITY AND A SYSTEM VERFIFICATION WAS SUCCESSFULLY RAN. AFTER THE INTERVENTION, THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS AND WAS RETURNED TO FULL OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770068 ↗
• MalfunctionOct 29, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON THE IH-1000 DURING FORWARD TYPING. THE PATIENT SAMPLE WAS RE-TESTED ON (B)(6) 2024 ON THE SAME INSTRUMENT AND WAS REPORTED AS O POSITIVE WITH NO FALSE POSITIVE REACTION IN THE ANTI-B WELL. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED WITH THE FOLLOWING RESULTS: THE SAMPLE (B)(6) HAS BEEN LOADED AT 15:53:53 ON LANE 5 POSITION 3. THE SAMPLE HAS BEEN PIPETTED BY THE LEFT PIPETTOR. THE NEEDLE HAS BEEN WASHED BEFORE AND AFTER MAKING THE RED BLOOD CELL SUSPENSION FOR THE TEST. THE RED BLOOD CELL SUSPENSION HAS BEEN PIPETTED FROM WELL 4 TO 1, IT MEANS CONTROL, ANTI-D, ANTI-B AND ANTI-A. THE WAITING TIME BETWEEN THE PIPETTING AND CENTRIFUGING WAS 15 MINUTES 41 SECONDS. THERE WAS NO ERROR DURING THE PROCESSING OF SAMPLE. THE PROCESSED GEL CARD IMAGE DOES NOT PRESENT ANY ANOMALIES, THE RESULT HAS BEEN CORRECTLY INTERPRETED BY THE ALGORITHM. THE PREVIOUS SAMPLE PIPETTED BY THE LEFT PIPETTOR IS (B)(6) WITH A B RHD POSITIVE RESULT, ALSO PIPETTED FROM WELL 4 TO 1. IN VIEW OF REVIEWED DATA, THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE RESULT ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555936 ↗
• MalfunctionSep 12, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THEIR IH-1000 INSTRUMENT WAS HAVING A "NO DISTRIBUTION" (LIQ) ISSUE. APPARENTLY, THEIR IH-1000 INSTRUMENT ADDED NO PLASMA TO WELLS 2 TO 6. WELL 1P WAS EDITED FROM LIQ TO NEGATIVE AFTER REVIEW BY THE OPERATOR AND APPEARED TO HAVE PLASMA. WELLS 2P - 6P APPEARED CLEAR AS THOUGH NO SAMPLE WERE ADDED BUT WERE NOT FLAGGED. WELLS 7P - 11P APPEARED TO HAVE PLASMA ADDED. ALL WELLS WERE NEGATIVE. TRACE FILES OF THE AFFECTED INSTRUMENT WERE REVIEWED AND A FIELD SERVICE ENGINEER WAS ON SITE TO EXANIMATE THE INSTRUMENT. THIS EXAMINATION STRONGLY SUGGESTED THAT THE PROBLEM WAS LINKED TO THE DISTRIBUTION MODULE (A MICRO-PUMP THAT DISPENSES THE LIQUID INTO THE WELLS) OR THE READING MODULE (THIS MODULE ALLOWS US TO READ CARDS WITH RESULTS). OUR ON-SITE TECHNICIAN REPLACED THESE PARTS, AND AFTER REPLACING , A FUNCTIONAL TEST WAS CARRIED OUT WITH NO ERRORS. THE INSTRUMENT HAS BEEN RETURNED TO THE CUSTOMER FOR CONTINUED USE. AFTER THIS INTERVENTION, THE INSTRUMENT WAS UNDER SURVEILLANCE FOR FIVE DAYS AND NO ERRORS REAPPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198718 ↗
• MalfunctionJun 3, 2024Leak/Splash; Leak/Splash

  A BIO-RAD FIELD SERVICE ENGINEER WAS ON THE CUSTOMER'S SITE FOR A PIPETTOR ISSUE AND DISCOVERED THE PUMP OF THE INSTRUMENT WAS BLACKENED AND PARTIALLY MELTED. NO DIRECT HARM HAPPEND TO ANYONE IN THE FACILITY; THE CUSTOMER WAS UNAWARE OF THIS INCIDENT AND HAD NOT WITNESSED OR SMELLED ANYTHING BURNING. THE ENGINEER PERFORMED A THOROUGH INVESTIGATION OF THE INSTRUMENT AND FOUND NO OTHER AFFECTED AREAS. THE PUMP AND WIRING ARRAY WERE REPLACED, THEN THE ENGINEER PERFORMED TESTINGS OF THE SYSTEM'S FLUIDICS SYSTEM, WHICH RESULTED IN NO ISSUES. THE INSTRUMENT WAS VERIFIED TO BE PERFORMING AT MANUFACTURING SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE MELTING OF THE PUMP WAS POSSIBLY CAUSED BY FLUID LEAKING ONTO THE PUMP'S ELECTRONIC COMPONENTS, HOWEVER THIS CANNOT BE FULLY VERIFIED AS THE DATE AND TIME OF INCIDENT IS UNKNOWN. THE FIELD ENGINEER WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE INSTRUMENT AND VERIFY THAT ALL FLUIDIC TUBING OF THE INSTRUMENT IS IN WELL CONNECTED AND IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445353 ↗
• MalfunctionApr 24, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON THE IH-1000. THE CUSTOMER STATED THAT SHE SAW THIS ISSUE WITH ABOUT 20 SAMPLES THAT WERE RUN ON BOTH SIDES OF THE INSTRUMENT. SHE HAS PRINTED 3 EXAMPLES FROM THE RESULTS TAB. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING AT CUSTOMER NO BLOOD GROUP WAS GENERATED BY THE IH-1000. THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE OF IH-CARD ABO/D(DVI-)+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THE RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WAS FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O SAMPLES. ALL POSITIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171001 ↗
• MalfunctionApr 24, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON THE IH-1000. THE CUSTOMER STATED THAT SHE SAW THIS ISSUE WITH ABOUT 20 SAMPLES THAT WERE RUN ON BOTH SIDES OF THE INSTRUMENT. SHE HAS PRINTED 3 EXAMPLES FROM THE RESULTS TAB. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING AT CUSTOMER NO BLOOD GROUP WAS GENERATED BY THE IH-1000. THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE OF IH-CARD ABO/D(DVI-)+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THE RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WAS FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O SAMPLES. ALL POSITIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171000 ↗
• MalfunctionApr 23, 2024Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS NOT POWERED ON AND THERE WAS A BURNING PLASIC/ELECTRICAL SMELL COMING FROM NEAR THE INSTRUMENT. NO SMOKE OR SOUNDS WAS NOTICED BY THE CUSTOMER. THE CUSTOMER WAS NOTIFIED BY THE TECHNICAL SERVICE TEAM TO NOT ATTEMPT TO USE THE INSTRUMENT AND UNPLUG THE POWER CABLE FROM THE WALL OUTLET. A FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER'S SITE. UPON ARRIVAL, THE FIELD SERVICE ENGINEER CONFIRMED WITH THE CUSTOMER THAT THE ISSUE OCCURRED AFTER AN ELECTRICAL ISSUE AT THE CUSTOMER SITE. THIS CAUSED A LARGE AMOUNT OF ELECTRICITY TO FLOW INTO THE INSTRUMENT'S UPS, OR BACKUP BATTERY, WHICH CAUSED IT TO OVERCHARGE AND FAIL. THE FIELD ENGINEER REPLACED THE UPS AND CONFIRMED NO DAMAGE TO CABLE SETUP OF THE INSTRUMENT. THERE WAS NO DAMAGE OR RISK OF FIRE FROM THE INSTRUMENT ITSELF. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161629 ↗
• MalfunctionAug 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE REACTIONS WERE RATED AS 1+ POSITIVE BUT YIELDED A NEGATIVE RESULT IN MANUAL GEL TESTING WITH THE SAME CARD LOT NUMBER. VISUAL INSPECTION OF THE IH-1000 PICTURES OF THE ABO/D CARDS HAD A HAZY APPEARANCE THE ANTI-B WELLS. THE CUSTOMER USED TWO DIFFERENT CARD LOTS AND WE FILED REPORTS 9610824-2023-00044, 9610824-2023-00045 & 9610824-2023-00046 FOR THE FIRST USED LOT OF IH-CARDS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601359 ↗
• MalfunctionAug 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE REACTIONS WERE RATED AS 1+ POSITIVE BUT YIELDED A NEGATIVE RESULT IN MANUAL GEL TESTING WITH THE SAME CARD LOT NUMBER. VISUAL INSPECTION OF THE IH-1000 PICTURES OF THE ABO/D CARDS HAD A HAZY APPEARANCE THE ANTI-B WELLS. THE CUSTOMER USED TWO DIFFERENT CARD LOTS AND WE FILED REPORTS 9610824-2023-00044, 9610824-2023-00045 & 9610824-2023-00046 FOR THE FIRST USED LOT OF IH-CARDS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601358 ↗
• MalfunctionAug 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE REACTIONS WERE RATED AS 1+ POSITIVE BUT YIELDED A NEGATIVE RESULT IN MANUAL GEL TESTING WITH THE SAME CARD LOT NUMBER. VISUAL INSPECTION OF THE IH-1000 PICTURES OF THE ABO/D CARDS HAD A HAZY APPEARANCE THE ANTI-B WELLS. THE CUSTOMER USED TWO DIFFERENT CARD LOTS AND WE FILED REPORTS 9610824-2023-00044, 9610824-2023-00045 & 9610824-2023-00046 FOR THE FIRST USED LOT OF IH-CARDS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601357 ↗
• MalfunctionAug 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE REACTIONS WERE RATED AS 1+ POSITIVE BUT YIELDED A NEGATIVE RESULT IN MANUAL GEL TESTING WITH THE SAME CARD LOT NUMBER. VISUAL INSPECTION OF THE IH-1000 PICTURES OF THE ABO/D CARDS HAD A HAZY APPEARANCE THE ANTI-B WELLS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE OR HAZY REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594974 ↗
• MalfunctionAug 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE REACTIONS WERE RATED AS 1+ POSITIVE BUT YIELDED A NEGATIVE RESULT IN MANUAL GEL TESTING WITH THE SAME CARD LOT NUMBER. VISUAL INSPECTION OF THE IH-1000 PICTURES OF THE ABO/D CARDS HAD A HAZY APPEARANCE THE ANTI-B WELLS. THE CUSTOMER USED TWO DIFFERENT CARD LOTS AND WE FILED REPORTS 9610824-2023-00047, 9610824-2023-00048 & 9610824-2023-00049 FOR THE SECOND USED LOT OF IH-CARDS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594934 ↗