TANGO optimo 848900010Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07611969961696), received between Jan 9, 2013 and Jul 11, 2019 — classified as 24 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2019False Positive Result; Defective Component; Material Twisted/Bent

  THE CUSTOMER REPORTED A DISCREPANT BLOOD GROUP RESULTS WHEN USING ERYTYPE S ABD+REV. A1, B ON TANGO OPTIMO. THE CUSTOMER STATED THAT A BLOOD GROUP A RHD POSITIVE CAME OUT AS BLOOD GROUP B RHD POSITIVE, POSSIBLY CAUSED BY CARRY OVER. THE CUSTOMER DID NEITHER PROVIDE THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1,B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER PROVIDED RESULT IMAGES. ONE IMAGES SHOWS UNEXPECTED POSITIVE RESULT INTERPRETATION IN THE ANTI-B WELL, WHICH CAN BE VISUALLY CONFIRMED. THE RESULT WAS SET TO INVALID AND INSTRUMENTS SOFTWARE GREYS OUT INVALID RESULTS. THEREFORE IT IS ONLY ASSUMED THAT THE ANTI-B WELL DOES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8779537 ↗
• MalfunctionOct 24, 2018False Negative Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ERYTYPECELL B ON ERYTYPE WHEN TESTING ON TANGO OPTIMO ON (B)(6) 2018. REPEAT TESTING OF THE SAMPLE ON TANGO OPTIMO AND IN THE TUBE YIELDED A 3+ POSITIVE RESULT. DUE TO THE INITIAL UNCLEAR COMPLAINT DESCRIPTION OF THE CUSTOMER IT WAS NOT CLEAR WHETHER THE FALSE NEGATIVE REACTION OCCURRED ON THE FORWARD TYPING WITH ERYTYPE S ABD+REV.A1, B OR ON THE REVERSE TYPING WITH ERYTYPECELL A1&B. BUT UPON REQUEST WE WERE INFORMED THAT THE FALSE NEGATIVE RESULT OCCURRED WITH ERYTYPECELL B OF ERYTYPECELL A1&B IN THE REVERSE TYPING ON TANGO OPTIMO. ON (B)(6) 2018 THE CUSTOMER PERFORMED NEW TESTS OF OTHER PATIENT SAMPLES AND GOT ONE FALSE NEGATIVE RESULT IN REVERSE TYPING WITH REAGENT RED BLOOD CELL A1 OF ERYTYPECELL A1&B. THE RESULT WAS CORRECTLY POSITIVE IN A REPEAT TESTING. ON (B)(6) 2018 THE CUSTOMER OBSERVED THE THIRD EVENT REGARDING INCORRECT RESULTS IN REVERSE TYPING. AN A POSITIVE PATIENT SAMPLE YIELDED A 1+ POSITIVE REACTION WITH ERYTYPECELL A1 AND A NEGATIVE REACTION WITH ERYTYPECELL B. ON (B)(6) 2018 THE CUSTOMER OBSERVED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WITH THE BLOOD GROUP O IN THE REVERSE TYPING. IN TOTAL CUSTOMER REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000186 ↗
• MalfunctionSep 26, 2018False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ERYTYPECELL B ON ERYTYPE WHEN TESTING ON TANGO OPTIMO ON (B)(6) 2018. REPEAT TESTING OF THE SAMPLE ON TANGO OPTIMO AND IN THE TUBE YIELDED A 3+ POSITIVE RESULT. DUE TO THE INITIAL UNCLEAR COMPLAINT DESCRIPTION OF THE CUSTOMER IT WAS NOT CLEAR WHETHER THE FALSE NEGATIVE REACTION OCCURRED ON THE FORWARD TYPING WITH ERYTYPE S ABD+REV.A1, B OR ON THE REVERSE TYPING WITH ERYTYPECELL A1&B. BUT UPON REQUEST WE WERE INFORMED THAT THE FALSE NEGATIVE RESULT OCCURRED WITH ERYTYPECELL B OF ERYTYPECELL A1&B IN THE REVERSE TYPING ON TANGO OPTIMO. ON (B)(6) 2018 THE CUSTOMER PERFORMED NEW TESTS OF OTHER PATIENT SAMPLES AND GOT ONE FALSE NEGATIVE RESULT IN REVERSE TYPING WITH REAGENT RED BLOOD CELL A1 OF ERYTYPECELL A1&B. THE RESULT WAS CORRECTLY POSITIVE IN A REPEAT TESTING. ON (B)(6) 2018 THE CUSTOMER OBSERVED THE THIRD EVENT REGARDING INCORRECT RESULTS IN REVERSE TYPING. AN A POSITIVE PATIENT SAMPLE YIELDED A 1+ POSITIVE REACTION WITH ERYTYPECELL A1 AND A NEGATIVE REACTION WITH ERYTYPECELL B. ON (B)(6) 2018 THE CUSTOMER OBSERVED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WITH THE BLOOD GROUP O IN THE REVERSE TYPING. IN TOTAL CUSTOMER REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909256 ↗
• MalfunctionSep 26, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ANTI-B ON ERYTYPE S ABD+REV. A1,B WHEN TESTED ON TANGO OPTIMO ON (B)(6) 2018. REPEAT TESTING OF THE SAMPLE ON TANGO OPTIMO AND IN THE TUBE YIELDED A 3+ RESULT. ON (B)(6) 2018 THE CUSTOMER PERFORMED NEW TESTS OF OTHER PATIENT SAMPLES AND GOT A FALSE NEGATIVE RESULT IN REVERSE TYPING WITH REAGENT RED BLOOD CELL A1 OF ERYTYPECELL A1,B LOT 8831011-00. ON (B)(6) 2018 THE CUSTOMER OBSERVED THE THIRD EVENT REGARDING FALSE REACTIONS IN REVERSE TYPING. AN A POS PATIENT SAMPLE YIELDED A 1+ REACTION WITH REAGENT RED BLOOD CELL A1 AND A NEGATIVE WITH REAGENT RED BLOOD CELL B. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCTS FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESPECTIVELY FALSE POSITIVE TEST RESULTS. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF BOTH ALLEGEDLY DEFECTIVE LOTS. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. EVALUATION OF THE DATA IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909174 ↗
• MalfunctionSep 26, 2018False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ANTI-B ON ERYTYPE S ABD+REV. A1,B WHEN TESTED ON TANGO OPTIMO ON (B)(6) 2018. REPEAT TESTING OF THE SAMPLE ON TANGO OPTIMO AND IN THE TUBE YIELDED A 3+ RESULT. ON (B)(6) 2018 THE CUSTOMER PERFORMED NEW TESTS OF OTHER PATIENT SAMPLES AND GOT A FALSE NEGATIVE RESULT IN REVERSE TYPING WITH REAGENT RED BLOOD CELL A1 OF ERYTYPECELL A1,B LOT 8831011-00. ON (B)(6) 2018 THE CUSTOMER OBSERVED THE THIRD EVENT REGARDING FALSE REACTIONS IN REVERSE TYPING. AN A POS PATIENT SAMPLE YIELDED A 1+ REACTION WITH REAGENT RED BLOOD CELL A1 AND A NEGATIVE WITH REAGENT RED BLOOD CELL B. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCTS FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESPECTIVELY FALSE POSITIVE TEST RESULTS. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF BOTH ALLEGEDLY DEFECTIVE LOTS. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. EVALUATION OF THE DATA IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909173 ↗
• MalfunctionAug 2, 2018Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED ABOUT FALSE BLOOD GROUP RESULT WHEN TESTING WITH ERYTYE S ABD REV A1,B ON TANGO OPTIMO. ONE PATIENT SAMPLE THAT WAS A TRUE A RH D POSITIVE WAS ASSIGNED THE TEST RESULT O RH D NEGATIVE. THE CUSTOMER RECEIVED A DISCREPANCY MESSAGE FROM LIS AS HISTORICAL DATA FROM THE PATIENT WAS KNOWN. REPEAT TESTING AND MANUAL TESTING CONFIRMED THE TRUE TYPE OF SAMPLE 1. THE SECOND SAMPLE (SAMPLE 2), A TRUE TYPE O RH D POSITIVE, WAS ASSIGNED A RH D POSITIVE AS A TEST RESULT BY THE INSTRUMENT. SAMPLE 2 WAS COMPLETED IMMEDIATELY AFTERWARD SAMPLE 1. THE FALSE BLOOD GROUP RESULT WAS OBSERVED ONCE FOR EACH SAMPLE, AFTER QC RUN. BASED ON THE DATA ANALYZED SO FAR, WE SUSPECT THAT THE INSTRUMENT PC ASSIGNED BOTH SAMPLES TO RACK 1, POSITION 1 AND 2. THESE RACKS WERE HOWEVER OCCUPIED BY QC SAMPLES. DUE TO THIS INCORRECT ASSIGNMENT OF SAMPLES, WRONG RESULTS WERE REPORTED BY THE INSTRUMENT. A WARNING MESSAGE OCCURRED JUST BEFORE THE TWO SAMPLES WERE LOADED: AS TO EVENT LOG: "BARCODE SCANNER NOT FUNCTIONING TO RESET THE BARCODE SCANNER PLEASE CLOSE THE DRAWER...."; THEN "RACK DATA ON TRACK 1 WERE DISCARDED." THE FIELD SERVICE ENGINEER WAS ON SITE AT THE TIME OF CUSTOMER REPORTING AND COULD

  Patient problems: No Information

  MAUDE report 7741735 ↗
• MalfunctionJan 22, 2018False Positive Result; Occlusion Within Device; Scratched Material

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO OPTIMO. THE CUSTOMER STATED THAT REACTIONS WERE NOT RESUSPENDED ON TANGO OPTIMO AND THEREFORE INTERPRETED AS BEING POSITIVE. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE SPECIMENS THAT HAD CAUSED FALSE POSITIVE REACTIONS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH DIFFERENT RED BLOOD CELLS ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL NEGATIVE REACTIONS WERE COMPLETELY RESUSPENDED. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS AND THE ORBITAL SHAKER'S WAS FOUND TO BE IN NEED OF REPAIR. THE RIGHT NEEDLE ADAPTER'S CABLE WAS DAMAGED, BUBBLES WERE FOUND INSIDE THE RIGHT SYRINGE AND SCRATCHES ON THE RIGHT NEEDLE. THE RIGHT SYRINGE, RIGH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208856 ↗
• MalfunctionSep 13, 2017Defective Component; Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED THAT SPORADICALLY, NOT RESUSPENDED ARTIFACTS OCCURED IN THE REVERSE 0 CELLS WHEN PROCESSING BLOOD TYPING USING ERYTYPE S AB0+D AND ERYTYPECELL ON TANGO OPTIMO. THE CUSTOMER STATED THAT NEGATIVE REACTIONS IN REVERSE TYPING LOOKED LIKE THERE WERE CRUMBLES IN IT. THESE ARTIFACTS DID CAUSE "+/-" RESULTS INSTEAD OF NEGATIVE TEST RESULTS ON TANGO OPTIMO JUST WITH TESTCELL 0. THE CUSTOMER PROVIDED PICTURES OF THE PHENOMENON AND DID RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT (ERYTYPE S AB0+D), ERYTYPECELL FOR INVESTIGATIONAL TESTING AND ALSO FOUR SPECIMENS THAT HAD CAUSED THAT PHENOMENON. THEREFORE OUR QUALITY CONTROL TESTED ALL COMPLAINED SAMPLES WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVES OR ARTEFACTS (CRUMBLES) IN REVERSE TYPING. TESTING BY THE QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S AB0+D FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND WAS CONFIRMED TO WOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861584 ↗
• MalfunctionSep 11, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED DISCREPANT TEST RESULTS ON A PATIENT SAMPLE KNOWN AS ANTI-KELL WHEN TESTING ON TANGO OPTIMO. THE SAMPLE SHOWED INITIALLY NEGATIVE TEST RESULTS WITH SCREENING CELL #1 (BIOTESTCELL 3). AFTER RECOLLECTING THE SAMPLE AND TESTING IT ON THE SECOND TESTING DAY WITH BIOTESTCELL 3 , THE SAMPLE SHOWED A POSITIVE REACTION (2+). THEY REPEATED TWO SAMPLES FROM THE DAY BEFORE AND OBTAINED A +/- TEST ON THE SCREENING CELLS. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT (BIOTESTCELL 3), THE USED AHG FOR SOLIDSCREEN II PLATES (SCII) AND THE TWO SAMPLES THAT HAD CAUSED THE DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINED BIOTESTCELL 3 LOT # 8727011-00 IN COMPARISON WITH THE RETAINED CURRENT LOT BIOTESTCELL 3 # 8731021-00 WITH DIFFERENT SAMPLES, CONTROLS AND WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER. ADDITIONALLY THE AHG FOR SC II WAS TESTED BY TITRATION IN PARALLEL TO THE RETAINED SAMPLE AND A REFERENCE LOT. THE PATIENT SAMPLES WERE CLEARLY IDENTIFIED TO HAVE AN ANTI-KELL. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT FOR ANTIBODY SCREEN. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALIT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854885 ↗
• MalfunctionSep 11, 2017False Negative Result; Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED DISCREPANT TEST RESULTS ON A PATIENT SAMPLE KNOWN AS ANTI-KELL WHEN TESTING ON TANGO OPTIMO. THE SAMPLE SHOWED INITIALLY NEGATIVE TEST RESULTS WITH SCREENING CELL #1 (BIOTESTCELL 3). AFTER RECOLLECTING THE SAMPLE AND TESTING IT ON THE SECOND TESTING DAY WITH BIOTESTCELL 3 , THE SAMPLE SHOWED A POSITIVE REACTION (2+). THEY REPEATED TWO SAMPLES FROM THE DAY BEFORE AND OBTAINED A +/- TEST ON THE SCREENING CELLS. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT (BIOTESTCELL 3), THE USED AHG FOR SOLIDSCREEN II PLATES (SCII) AND THE TWO SAMPLES THAT HAD CAUSED THE DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINED BIOTESTCELL 3 LOT # 8727011-00 IN COMPARISION WITH THE RETAINED CURRENT LOT BIOTESTCELL 3 # 8731021-00 WITH DIFFERENT SAMPLES, CONTROLS AND WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER. ADDITIONALLY THE AHG FOR SC II WAS TESTED BY TITRATION IN PARALLEL TO THE RETAINED SAMPLE AND A REFERENCE LOT. THE PATIENT SAMPLES WERE CLEARLY IDENTIFIED TO HAVE AN ANTI-KELL. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT FOR ANTIBODY SCREEN. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY O

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854867 ↗
• MalfunctionAug 7, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE YIELDED A FALSE NEGATIVE RESULT WITH BIOTESTCELL-P3 ON TANGO OPTIMO, (B)(4). TWO OTHER TANGO OPTIMO INSTRUMENTS YIELDED A POSITIVE RESULT WITH THIS SAMPLE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR BIOTESTCELL-P3 RETENTION SAMPLE WITH DIFFERENT ANTIBODIES AND CONTROLS (INCLUDING ANTI-D,-C,-E,-FYA,-JKA, K). ADDITIONAL A TITRATION OF SOLIDSCREEN II CONTROL (ANTI-D) WAS PERFORMED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTIONALITY OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-P3. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS CONFIRMED TO RUN WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES ON THE DATES OF TESTING. BUT IT WAS RECOGNIZED THAT THE SAMPLE WAS FIRST LOADED ON THIS INSTRUMENT AT 10:31 ON (B)(6) 2017 I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6770009 ↗
• MalfunctionAug 7, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE YIELDED A FALSE NEGATIVE RESULT WITH BIOTEST CELL-P3 ON TANGO OPTIMO #9142400349. TWO OTHER TANGO OPTIMO INSTRUMENTS YIELDED A POSITIVE RESULT WITH THIS SAMPLE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR BIOTEST CELL-P3 RETENTION SAMPLE WITH DIFFERENT ANTIBODIES AND CONTROLS (INCLUDING ANTI-D,-C,-E,-FYA,-JKA, K). ADDITIONAL A TITRATION OF SOLIDSCREEN II CONTROL (ANTI-D) WAS PERFORMED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTIONALITY OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL-P3. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS CONFIRMED TO RUN WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES ON THE DATES OF TESTING. BUT IT WAS RECOGNIZED THAT THE SAMPLE WAS FIRST LOADED ON THIS INSTRUMENT AT 10:31 ON (B)(6)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6770000 ↗
• MalfunctionJul 5, 2017False Negative Result

  THE CUSTOMER REPORTED THAT SHE MISSED AN ANTI-E AND ANTI-K WHEN USING BIOTEST CELL 1 AND 2 ON TANGO OPTIMO SN #(B)(4). BOTH SAMPLES WERE RERAN ON TANGO OPTIMO SN #(B)(4) AND YIELDED CORRECTLY POSITIVE RESULTS. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL 1 AND 2 NOR THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL 1 AND 2 WITH SAMPLES AND CONTROLS, E.G. ANTI-E AND ANTI-K OF PROFICIENCY TESTING ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1 AND 2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE WASH MANIFOLD WAS CLEANED AND THE NEEDLE ALIGNMENTS VERIFIED. A QC RUN THAT WAS PERFORMED AFTER THIS "INVENTIN" SHOWED GOOD RESULTS. THE PATIENT SAMPLE WAS RUN AND THE INSTRUMENT WAS ABLE TO DETECT THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685545 ↗
• MalfunctionJul 5, 2017False Negative Result

  THE CUSTOMER REPORTED THAT SHE MISSED AN ANTI-E AND ANTI-K WHEN USING BIOTESTCELL 1&2 ON TANGO OPTIMO SN #(B)(4). BOTH SAMPLES WERE RERAN ON TANGO OPTIMO SN #(B)(4) AND YIELDED CORRECTLY POSITIVE RESULTS. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 1&2 NOR THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL 1&2 WITH SAMPLES AND CONTROLS, E.G. ANTI-E AND ANTI-K OF PROFICIENCY TESTING ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE WASH MANIFOLD WAS CLEANED AND THE NEEDLE ALIGNMENTS VERIFIED. A QC RUN THAT WAS PERFORMED AFTER THIS INVENTION SHOWED GOOD RESULTS. THE PATIENT SAMPLE WAS RUN AND THE INSTRUMENT WAS ABLE TO DETECT THE ANTIBODY. SYSTEM PE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685534 ↗
• MalfunctionMay 23, 2017False Negative Result; Defective Device

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TANGO OPTIMO AND THE ID-CARD SYSTEM. WHEN PROCESSING AN ANTIBODY SCREENING TEST AND AN AUTOCONTROL OF ONE PATIENT SAMPLE WITH ANTI-HUMAN-GLOBULIN SOLIDSCREEN II, THE CUSTOMER'S TANGO OPTIMO EVALUATED THE RESULT AS NEGATIVE BUT VISUALLY IT WAS POSITIVE. A CROSSMATCH OF TWO PATIENTS WAS NEGATIVE USING THE TANGO OPTIMO BUT POSITIVE WHEN TESTING WITH THE ID-CARD SYSTEM. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINED MATERIAL RETURNED BY THE CUSTOMER IN COMPARISON TO THEIR RETAINED AHG SOLIDSCREEN II SAMPLE AND ANOTHER RELEASED REAGENT. THE ALLEGEDLY DEFECTIVE AHG SOLIDSCREEN II, LOT.2640100-00 YIELDED CLEAR AND CORRECT RESULTS. THEN AN ANTIBODY SCREEN TEST AS WELL AS AN AUTOCONTROL WAS CONDUCTED BY USING THE COMPLAINT REAGENTS AND THE PROVIDED PATIENT SAMPLES FROM THE CUSTOMER. TESTING WAS DONE WITH POSITIVE AND NEGATIVE CONTROLS AND A KNOWN ANTI-JK(A). THE ANTIBODY SCREEN WAS POSITIVE AND SO WAS THE AUTOCONTROL. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. CROSSMATCH TESTING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6583782 ↗
• MalfunctionApr 5, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A SAMPLE WHEN TESTED WITH BIOTESTCELL-I11 ON TANGO OPTIMO S/N #(B)(4). THE SAMPLE WAS RERUN ON TANGO OPTIMO S/N # (B)(4) AND YIELDED CORRECT POSITIVE RESULTS WITH CELL #2 AND CELL #8 OF BIOTESTCELL-I11. THE FINAL RESULT WAS ANTI-K. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO OPTIMO, INCLUDING AN ANTI-K. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. DURING THIS SERVICE VISIT, THE WASH MANIFOLD WAS REPLACED. UPON PERFORMING PREVENTIVE MAINTENANCE PER CHECKLIST, THE QC RUNS WERE PASSED WITH ACCEPTABLE RESULTS. THE INSTRUMENT IS WORKING WITHIN ITS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6459661 ↗
• MalfunctionMar 23, 2017Use of Device Problem

  A CLEAR LIQUID SPLASH FROM SUSPENSION CUP WENT INTO CUSTOMER'S EYE WHEN THE CUSTOMER WAS IN THE PROCESS OF PERFORMING THE MONTHLY MAINTENANCE ON THEIR TANGO OPTIMO. THE CUSTOMER HAD REMOVED THE DISPOSABLE CUP AND THE SPLASH BOWL. SHE HAD RINSED BOTH WITH DI WATER, BUT DID NOT NOTICE REMAINING LIQUID ON THE SPLASH BOWL.THE CUSTOMER WAS WEARING GLASSES BUT THE LIQUID WENT UP UNDER HER GLASSES. THIS IS A CASE OF UNINTENDED USE BY THE CUSTOMER. WE KINDLY SUGGEST CAREFULLY INSPECTING THE SPLASH BOWL FOR ANY REMAINING LIQUID AND IN EITHER CASE WEARING SAFETY GLASSES. NO INFORMATION WAS PROVIDED ABOUT THE CUSTOMER'S CONDITION. BUT, DUE TO THE PRESENCE OF CLEAR LIQUID (PROBABLY WATER) INSIDE THE SPLASH, IT IS ASSUMED THAT THE CUSTOMER WAS NOT INJURED. WE WILL OFFER A REFRESHER COURSE FOR THE CUSTOMER IN ORDER TO AVOID THIS KIND OF SPLASH IN THE FUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6427120 ↗
• MalfunctionFeb 8, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE CROSSMATCH RESULT OF A PROFIENCY SAMPLE WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II WHEN USED ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT TANGO OPTIMO CALLED THE RESULT NEGATIVE, BUT WHEN SHE ENLARGED THE IMAGE, THE RESULT APPEARED TO BE POSITIVE. THE CUSTOMER REPORTED THAT THE FALSE NEGATIVE REACTION OCCURRED WHEN FY(A) POSITIVE PROFICIENCY RED BLOOD CELLS WERE TESTED WITH AN PROFICIENCY SAMPLE CONTAINING AN ANTI-FY(A). THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PROFICIENCY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II IN CROSSMATCH ON TANGO OPTIMO. FOR CROSSMATCH TESTING RED BLOOD CELLS WITH DIFFERENT ANTIGEN CONSTELLATIONS, E.G. FY(A) POSITIVE AND DIFFERENT SAMPLES, INCLUDING ANTI-FY(A) WERE USED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. OUR QUALITY CONTROL LABORATORY HAD ALSO PARTICIPATED IN THE SAME PROFICIENCY TEST THAT THE CUSTOMER COMPLAINED AND HAD PASSED. IN QUALITY CONTROL TESTING THE PROFICIE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6310294 ↗
• MalfunctionFeb 8, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE CROSSMATCH RESULT OF A PROFIENCY SAMPLE WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II WHEN USED ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT TANGO OPTIMO CALLED THE RESULT NEGATIVE, BUT WHEN SHE ENLARGED THE IMAGE, THE RESULT APPEARED TO BE POSITIVE. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PROFICIENCY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. THE AFFECTED INSTRUMENT TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD-SERVICE-ENGINEERS. EVALUATION OF THE DATA IS STILL ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6310291 ↗
• MalfunctionOct 25, 2016False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A PATIENT SAMPLE WHEN TESTED WITH ANTI-HUMAN-GLOBULIN SOLIDSCREEN II ON TANGO OPTIMO. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT. UPON ARRIVAL ON OUR PREMISES THE PATIENT SAMPLE WAS VERY HAEMOLYTIC. NEVERTHELESS THE PATIENT SAMPLE WAS TESTED WITH THE QC LAB'S RETAINED SAMPLE OF ANTI-HUMAN-GLOBULIN ON TANGO OPTIMO. THE REACTIONS WERE ASSESSED BY TANGO OPTIMO AS BEING POSITIVE. BUT DUE TO THE HEMOLYSIS OF THE PATIENT SAMPLE THE QUANTITY OF RED CELLS WAS NOT SUFFICIENT TO OBTAIN A VALID TEST RESULT. THE QC LAB'S RETAINED PRODUCT SAMPLE WAS ALSO TESTED WITH IGG SENSITIZED RED CELLS AND SHOWED CORRECT POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS WITH NO INDICATION FOR AN INSTRUM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6053302 ↗
• MalfunctionSep 1, 2016Disassembly; Inadequate Instructions for Healthcare Professional; Device Displays Incorrect Message

  THE CUSTOMER INJURED HER HAND WHILE REPLACING A PART ON TANGO OPTIMO. THE CUSTOMER TOOK OFF THE PART ABOVE THE PLATE LOADING AREA TO TAKE OFF THE COVER SURROUNDING THE PLATE STACKER. DURING THAT TIME, THE TANGO OPTIMO WAS SWITCHED OFF. THIS WAS NOT ADVISED TO HER FROM OUR TECHNICAL SERVICE. THE CUSTOMER HAD ALREADY DONE THIS ON HER OWN AND NOTIFIED THE BLOOD BANK SPECIALIST OF HER INJURY. THE CUSTOMER HAD A SOFTWARE ERROR AND IT APPEARED THAT NO PLATES WERE ON BOARD. THE CUSTOMER DID NOT CALL TECH SUPPORT AND THOUGHT THE ONLY WAY TO UNLOAD PLATES WAS TO GO IN AND MANUALLY TAKE THE PLATES OUT. SHE WAS NOT A CUSTOMER TRAINED ON THE TANGO OPTIMO. THE CUSTOMER TOOK THE COVERS OFF THE ENTIRE PLATE STACKER AREA AND HAD TROUBLE PLACING A PART BACK ON. WE RECEIVED INFORMATION THAT THE PINCH THE CUSTOMER SUFFERED WAS HARMLESS, THE CUSTOMER IS FINE AND THERE IS NO MARK, CUT OR SCRAPE. THIS INCIDENT HAPPENED BECAUSE OF UNINTENDED USE BY THE CUSTOMER. THE CUSTOMER WAS NOT QUALIFIED TO DO THE TROUBLESHOOTING AND DID NOT CALL TECH SUPPORT. REGARDING THE HARMLESS INJURY, THE CUSTOMER STATED SHE WAS FINE. WE CONSIDER OFFERING A REFRESHER COURSE FOR THE CUSTOMER IN ORDER TO AVOID THIS KIND OF INJUR

  Patient problems: Injury

  MAUDE report 5920415 ↗
• MalfunctionAug 26, 2016Device Reprocessing Problem; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE TANGO OPTIMO REPORTED A FALSE ANTIBODY SCREENING RESULT AND ONE FALSE BLOOD GROUP RESULT ON THREE CORD BLOOD SAMPLES, BUT RE-TESTING YIELDED CORRECT TEST RESULTS. OUR FIELD SERVICE ENGINEER INSPECTED THE AFFECTED TANGO OPTIMO AND FOUND THAT THE PIPETTOR NEEDLES WERE NOT CLEANED. OUR FIELD SERVICE ENGINEER CHANGED THE 3X3 VALVE BLOCK, WHICH IS RESPONSIBLE FOR THE DESCRIBED ISSUE, BECAUSE THE VALVE BLOCK WAS OUT OF FUNCTION. THE NEW VALVE BLOCK FUNCTION WAS CHECKED. ALL LIQUIDS WERE CORRECTLY TRANSPORTED. PERFORMING OF TEST RUNS YIELDED ACCEPTABLE RESULTS. THE CUSTOMER'S COMPLAINT COULD BE CONFIRMED. A REPAIR INTERVENTION SOLVED THE ISSUE AND AFTER THE AFFECTED INSTRUMENT PART THE TANGO OPTIMO WAS EXCHANGED, THE INSTRUMENT GENERATED RESULTS AS EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5905869 ↗
• MalfunctionJan 16, 2013False Negative Result; False Negative Result

  Patient problems: Anemia

  MAUDE report 2917198 ↗
• MalfunctionJan 9, 2013False Positive Result; False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 2902877 ↗