Chemstrip 10 MD Test Strips 3260763160Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00075537313121), received between Aug 23, 2018 and Apr 2, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025False Negative Result; Device Difficult to Setup or Prepare; False Negative Result; Device Difficult to Setup or Prepare

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CHEMSTRIP 10 MD URINE TEST STRIPS LEUKOCYTES RESULT FROM THE URISYS 1100 URINE ANALYZER. THE OPERATOR NOTED SEEING A POSITIVE LEUKOCYTE RESULT AS THEY WERE LOADING THE TEST STRIP ON THE 1100 ANALYZER. THE 1100 ANALYZER GAVE A NEGATIVE LEUKOCYTE RESULT. THE SAME SAMPLE WAS RE-TESTED ON (B)(6) 2025 AND READ VISUALLY WITH A RESULT OF 2+ LEUKOCYTES. A URINE CULTURE WAS SENT OUT, AND THE RESULTS WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752323 ↗
• MalfunctionFeb 10, 2025Incorrect Measurement; Device Difficult to Setup or Prepare; Incorrect Measurement; Device Difficult to Setup or Prepare

  THERE WAS AN ALLEGATION OF QUESTIONABLE NEGATIVE PROTEIN RESULTS FOR APPROXIMATELY 6 PATIENT SAMPLES ON A URISYS 1100. IT WAS ALLEGED THAT THE VISUAL RESULTS WERE 2 COLOR BLOCKS OUT (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347047 ↗
• MalfunctionOct 14, 2024False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT NEGATIVE RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH THE CHEMSTRIP 10 MD URINE TEST STRIPS WHEN COMPARED TO A MICROSCOPIC URINANALYSIS TESTING. THE LEUCOCYTES RESULT FROM THE URINE TEST STRIP WAS VISUALLY READ AS NEGATIVE WHILE IT RESULTED IN A LEUCOCYTES VALUE OF >100 WHEN IT WAS TESTED MICROSCOPICALLY. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE CUSTOMER STATED THAT THE PHYSICIAN SENT OUT THE SAMPLES FOR RE-TESTING BECAUSE SYMPTOMS WERE SHOWN ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438483 ↗
• MalfunctionMay 20, 2024False Negative Result; No Device Output; False Negative Result; No Device Output

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ERYTHROCYTE RESULT USING CHEMSTRIP 10 MD AND THE URISYS 1100 URINE ANALYZER. THE INITIAL RESULT WAS NEGATIVE. THE VISUAL READING OF REPEAT TESTING OF THE SAME SAMPLE GAVE A RESULT OF 50 ERY/UL. THE CUSTOMER NOTED RBCS PRESENT ON THE MICROSCOPIC EXAM OF THE SEDIMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350567 ↗
• MalfunctionMar 16, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED RESULTS FOR ERYTHROCYTES FROM 2 URINE SAMPLES FROM 1 PATIENT RUN ON 3 DIFFERENT URISYS 1100 INSTRUMENTS USING THE SAME STRIP LOT NUMBER. THE URISYS 1100 SERIAL NUMBERS ARE: (B)(4) (METER A), (B)(4) (METER B), AND (B)(4) (METER C). THE URINE SAMPLE TESTED ON METER A WAS A FRESHLY VOIDED SAMPLE OBTAINED IN THE DOCTOR¿S OFFICE ON (B)(6)2023. THE URINE SAMPLE TESTED ON METER B AND METER C WAS A URINE SAMPLE THE PATIENT BROUGHT IN FROM HOME THAT WAS ALSO VOIDED ON (B)(6)2023 INTO "WHATEVER CONTAINER THE PATIENT HAD AVAILABLE." AT APPROXIMATELY 9:00 A.M. THE SAMPLE OBTAINED IN THE OFFICE WAS RUN ON METER A WITH A NEGATIVE RESULT. THE URINE SAMPLE THE PATIENT BROUGHT FROM HOME WAS RUN ON METER C WITH A NEGATIVE RESULT. THE URINE SAMPLE THE PATIENT BROUGHT FROM HOME WAS RUN ON METER B WITH A POSITIVE RESULT (50 ERY/UL). THE CUSTOMER WAS NOT SURE WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555575 ↗
• MalfunctionFeb 20, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED A RESULT FOR 1 PATIENT TESTED FOR LEUKOCYTES ON A URISYS 1100 URINE ANALYZER. THE REPORTER ALLEGED THE ANALYZER BEGAN TO COUNTDOWN AT 45 SECONDS INSTEAD OF 60 SECONDS. THE ANALYZER RESULT FROM A 45-SECOND COUNTDOWN WAS "NORMAL." THE CUSTOMER REPEATED THE TEST WITH A VISUAL CHECK DUE TO THE 45-SECOND COUNTDOWN ON THE METER INSTEAD OF A 60-SECOND COUNTDOWN. THE RESULT FROM THE VISUAL CHECK AT 60 SECONDS WAS 2+ (POSITIVE). THE POSITIVE VISUAL RESULT WAS BELIEVED TO BE CORRECT. THE URISYS 1100 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404058 ↗
• MalfunctionDec 22, 2022No Device Output; Non Reproducible Results; No Device Output; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BLOOD, KETONES, AND PROTEIN RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A URISYS 1100 ANALYZER WITH SERIAL NUMBER (B)(4). THE RESULTS WERE COMPARED TO ACCUTEST TEST STRIPS AND A PRECISION URINE ANALYZER. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEY WOULD RUN THE VISUAL TEST USING ACCUSTRIP TEST STRIPS AND THE RESULTS WOULD BE NEGATIVE. AT THE SAME TIME, THE SAMPLE WOULD BE RUN ON THE ANALYZER AND THE BLOOD, KETONES, AND PROTEIN RESULTS WOULD BE "ABNORMAL." THE REPORTER COULD NOT DETERMINE IF THEY ALL OCCURRED SIMULTANEOUSLY, BUT THESE PARAMETERS WOULD SHOW "ABNORMAL" ON THE URINE ANALYZER. THE REPORTER COULD NOT QUANTIFY THE "ABNORMAL" RESULTS RECEIVED. THE REPORTER STATED THAT THE URINE WOULD BE CULTURED AND 2-3 DAYS LATER AND THEY WOULD COME UP NEGATIVE. THE REPORTER STATED THE RESULTS WOULD ALSO BE NEGATIVE ON A NON-ROCHE ANALYZER (PRECISION URINE ANALYZER). THE NEGATIVE RESULTS FROM THE VISUAL READ ON THE ACCUSTRIPS, THE NON-ROCHE ANALYZER AND THE URINE CULTURE WERE DEEMED CORRECT. THE CHEMSTRIP 10 LOT NUMBER IS 64616808 WITH AN EXPIRATION DATE OF 30-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036378 ↗
• MalfunctionNov 23, 2021False Negative Result; False Negative Result

  THERE WAS A COMPLAINT OF A QUESTIONABLE LEUKOCYTE RESULT FOR 1 PATIENT TESTED WITH A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S INITIAL METER RESULT WAS NEGATIVE. THE CUSTOMER LOOKED AT THE SAMPLE UNDER THE MICROSCOPE AND SAW APPROXIMATELY 20 - 30 WHITE CELLS. THE CUSTOMER RERAN THE SAME SAMPLE, SAME STRIP VIAL ON THE METER, AND GOT A RESULT OF 2+ OR 500 LEU/UL. THE TIMING BETWEEN TESTS WAS WITHIN 15 MINUTES. THE SAMPLE TYPE WAS URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860228 ↗
• MalfunctionNov 14, 2018High Test Results; High Test Results

  THE RETENTION MATERIAL OF LOT #25566400 WAS MEASURED ON AN IU URISYS 1100 WITH 0-NATIVE URINE AND A NITRITE-DILUTION-SERIES AND WAS VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071265 ↗
• MalfunctionNov 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF A FALSE NEGATIVE ERYTHROCYTE RESULT FOR 1 PATIENT URINE SAMPLE THAT WAS TESTED ON A URISYS 1100 URINE ANALYZER WITH SERIAL NUMBER (B)(4) AND COMPARED TO AN UNKNOWN LABORATORY METHOD. THE INITIAL ERYTHROCYTE RESULT FROM THE URISYS WAS NEGATIVE. THE SAMPLE WAS SENT TO ANOTHER HOSPITAL AND A RESULT OF 3 OR 4 PLUS. THE CUSTOMER COULD NOT REMEMBER THE EXACT TIME BETWEEN THE MEASUREMENTS BUT DID STATE THAT THEY WERE DONE BETWEEN 6-24 HOURS OF EACH OTHER. THE ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. QC TESTING WAS PERFORMED WITH ACCEPTABLE RESULTS. THE METER AND TEST STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION. THE RETENTION MATERIAL OF THE LOT 32223100 WAS MEASURED ON AN IU U 1800 ANALYZER WITH 0-NATIVE URINE, AND AN ERYTHROCYTES-DILUTION-SERIES. NO FALSE NEGATIVE RESULTS WERE OBSERVED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060594 ↗
• MalfunctionNov 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE NITRITE AND ERYTHROCYTES RESULTS FOR PATIENT URINE SAMPLES FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE NITRITE RESULT FROM THE METER WAS NEGATIVE AND THE RESULT WAS POSITIVE WITH THE VISUAL TEST. THE ERYTHROCYTES RESULT FROM THE METER WAS NEGATIVE AND THE RESULT WAS POSITIVE WITH THE VISUAL TEST. THE SPECIFIC DATE OF THE MEASUREMENTS WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE QC WAS ACCEPTABLE. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 27638300 WAS MEASURED ON A URISYS 1800 ANALYZER AND WAS VISUALLY CHECKED WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE NEGATIVE RESULTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059677 ↗
• MalfunctionNov 8, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE (B)(6) NITRITE RESULTS FOR TWO PATIENT URINE SAMPLES FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE NITRITE RESULTS FROM THE METER WERE (B)(6). THE CUSTOMER STATED THAT ONE PATIENT HAD A NEGATIVE RESULT WITH A VISUAL TEST USING A DIFFERENT TEST STRIP. IT WAS NOT CLEAR IF A VISUAL TEST WAS PERFORMED FOR THE OTHER PATIENT. THE PATIENTS WERE SENT HOME AFTER THE (B)(6) NITRITE RESULTS. LATER IN THE DAY, BOTH PATIENTS WENT TO THE EMERGENCY ROOM BECAUSE THEY WERE NOT FEELING WELL. THE CUSTOMER STATED THAT ONE PATIENT WAS TREATED FOR A URINARY TRACT INFECTION. IT WAS UNCERTAIN WHAT THE SECOND PATIENT WAS TREATED FOR AND WHAT THE TREATMENT WAS. THERE WAS NO ADDITIONAL INFORMATION ABOUT THE TREATMENT PROVIDED FOR EITHER PATIENT OR THE CURRENT STATUS OF THE PATIENTS. THIS INFORMATION WAS REQUESTED. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050429 ↗
• MalfunctionOct 31, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THERE WERE DISCREPANT LEUKOCYTES, PROTEIN, ERYTHROCYTE, AND GLUCOSE RESULTS. THE INITIAL LEUKOCYTES RESULT WAS 75 LEU/UL AND THE REPEAT RESULT WAS 500 LEU/UL. THE INITIAL PROTEIN RESULT WAS TRACE AND THE REPEAT RESULT WAS 500 MG/DL. THE INITIAL ERYTHROCYTE RESULT WAS NEGATIVE AND THE REPEAT RESULT WAS 250 ERY/UL. THE INITIAL GLUCOSE RESULT WAS 50 MG/DL AND THE REPEAT RESULT WAS NEGATIVE. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THAT THE STRIP TEST PADS VISUALLY APPEARED THE SAME COLOR. THE CALIBRATION AND QC WERE ACCEPTABLE. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023107 ↗
• MalfunctionOct 29, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF (B)(6) RESULTS FOR PATIENT URINE SAMPLES TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE LEUKOCYTES, NITRITE, AND ERYTHROCYTES RESULTS WERE (B)(6) ON THE URISYS 1100. THE RESULTS WERE (B)(6) WITH A VISUAL INSPECTION AND THE LABORATORY CULTURE WAS (B)(6). THE SPECIFIC RESULTS WERE NOT PROVIDED. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8013579 ↗
• MalfunctionOct 26, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE RESULTS FOR 1 PATIENT URINE SAMPLE FROM CHEMSTRIP 10 SG TEST STRIP ON A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE NITRITE AND LEUKOCYTES RESULTS FROM THE METER WERE NEGATIVE. THE URINE SAMPLE WAS SENT TO THE LABORATORY FOR A CULTURE. THE LABORATORY CULTURE WAS POSITIVE FOR ESCHERICHIA COL (E.COLI). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT'S CONDITION WAS "GOOD". THE CUSTOMER WAS NOT USING LIQUID QC. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008604 ↗
• MalfunctionOct 25, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF A FALSE NEGATIVE NITRITE RESULT FOR 1 PATIENT URINE SAMPLE FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE NITRITE RESULT FROM THE METER WAS NEGATIVE. THE CUSTOMER PERFORMED A VISUAL TEST AND THE NITRITE RESULT WAS POSITIVE. IT WAS NOT CLEAR IF THERE WAS ANY ADVERSE EVENT THE OCCURRED. CLARIFICATION HAS BEEN REQUESTED. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 29191100 WAS MEASURED ON AN URISYS 1800 ANALYZER WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS ARE ACCEPTABLE. NO FALSE NEGATIVE RESULTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8004137 ↗
• MalfunctionOct 19, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE NITRITE AND LEUKOCYTES RESULTS FOR SOME PATIENT URINE SAMPLES FROM CHEMSTRIP 10 SG TEST STRIPS ON A URYSIS 1100 SERIAL NUMBER (B)(4). THE CUSTOMER PROVIDED EXAMPLES. THE PATIENT HAD SYMPTOMS OF A URINARY TRACT INFECTION BUT THE NITRITE AND LEUKOCYTES RESULTS WERE NEGATIVE. THE SAMPLE WAS SENT TO THE LABORATORY. THE NITRITE AND LEUKOCYTES RESULTS WERE POSITIVE IN THE LABORATORY. THE CUSTOMER STATED THAT IN OTHER CASES THE NITRITE AND LEUKOCYTES RESULTS WERE POSITIVE FOR A TEST STRIP AND NEGATIVE FOR A DIFFERENT TEST STRIP. THE CUSTOMER DID NOT BELIEVE THE FIRST RESULTS WERE CORRECT. THE CUSTOMER SUSPECTED CONTAMINATION AND CLEANED THE INSTRUMENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CALIBRATION WAS ACCEPTABLE. THE CUSTOMER WAS NOT USING QC. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 29191100 WAS MEASURED ON AN URISYS 1800 ANALYZER WITH NATIVE URINE AND A NITRITE DILUTION SERIES AND A LEUCOCYTE DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE NEGATIVE RESULTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984424 ↗
• MalfunctionOct 16, 2018False Negative Result; False Negative Result

  THE CUSTOMER RECEIVED QUESTIONABLE LOW LEUKOCYTE AND FALSE NEGATIVE NITRITE RESULTS FOR QUALITY CONTROL MATERIAL AND PATIENT SAMPLES FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, ONLY THE NITRITE RESULTS WERE DISCREPANT. AROUND 8 AM, THE PATIENT URINE SAMPLE WAS TESTED ON THE URISYS 1100 AND THE RESULT WAS NEGATIVE FOR NITRITE. THE CUSTOMER PERFORMED A MICROSCOPIC EXAM OF THE SAMPLE UNDER A 40X MAGNIFICATION AND FOUND BACTERIA WAS PRESENT. THE SAMPLE WAS THEN CULTURED AND SHOWED GREATER THAN 100000 COL/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT KNOW THE DIAGNOSIS PROVIDED TO THE PATIENT AND DID NOT KNOW WHAT TREATMENT THE PATIENT RECEIVED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT URISYS 1100 AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970331 ↗
• MalfunctionOct 4, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE NITRITE RESULTS FOR 1 PATIENT URINE SAMPLE ON TWO URISYS 1100 ANALYZERS. THE RESULT WAS POSITIVE ON URISYS 1100 SERIAL NUMBER (B)(4). THE RESULT WAS NEGATIVE ON URISYS 1100 SERIAL NUMBER (B)(4). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR FELT THE NEGATIVE RESULT WAS CORRECT BASED ON THE PATIENT SYMPTOMS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933473 ↗
• MalfunctionSep 14, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE LEUKOCYTES AND NITRITE RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). AT 11:57 AM, THE LEUKOCYTES AND NITRITE RESULT WERE NEGATIVE. THE CUSTOMER SUSPECTED THAT THERE WAS AN ISSUE AND SENT THE PATIENT TO THE LABORATORY. THE SPECIFIC LABORATORY RESULTS WERE NOT PROVIDED BUT THE PATIENT HAD A POSITIVE CULTURE FOR E. COLI. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT WAS TREATED BASED ON THE LABORATORY RESULTS. THE PATIENT'S CONDITION WAS "OKAY". THE CUSTOMER HAD NOT RUN QC. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876360 ↗
• MalfunctionSep 4, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE PROTEIN, GLUCOSE, KETONES, ERYTHROCYTES, AND NITRITE RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1000 URINE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THERE WAS A DISCREPANT NITRITE RESULT COMPARED TO A LABORATORY ANALYZER. THE NITRITE RESULT WAS POSITIVE ON THE URISYS 1000 ANALYZER. THE NITRITE RESULT WAS NEGATIVE ON THE LABORATORY ANALYZER. THE LABORATORY METHOD WAS ASKED FOR BUT NOT PROVIDED. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842885 ↗
• MalfunctionSep 4, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE ERYTHROCYTES AND LEUKOCYTES RESULTS FOR 2 PATIENT URINE SAMPLES TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1000 URINE ANALYZER SERIAL NUMBER (B)(4). THE ERYTHROCYTES RESULTS WERE NEGATIVE ON THE URISYS 1000 ANALYZER. APPROXIMATELY 60 TO 120 SECONDS LATER ON A DIFFERENT URISYS 1000 ANALYZER AND WITH A VISUAL EVALUATION, THE ERYTHROCYTES RESULTS WERE >50 ERY/UL (POSITIVE). THE LEUKOCYTES RESULTS WERE NEGATIVE ON THE URISYS 1000 ANALYZER. ON A DIFFERENT URISYS 1000 ANALYZER AND WITH A VISUAL EVALUATION, THE LEUKOCYTES RESULTS WERE POSITIVE 60 SECONDS LATER. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENTS DID NOT RECEIVE TREATMENT BASED ON THE RESULTS. THE CUSTOMER WAS AWARE OF AN ISSUE DUE TO THE FALSE NEGATIVE RESULTS. THE CALIBRATION WAS SUCCESSFUL. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842629 ↗
• MalfunctionAug 23, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR OVER 40 PATIENT URINE SAMPLES ON A URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) SINCE (B)(6) 2018. THE SPECIFIC RESULTS WERE ASKED FOR BUT NOT PROVIDED. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO TREATMENT OR ACTIONS WERE TAKEN BASED ON THE RESULTS. THE CUSTOMER STATED THAT THEY DIPPED A TEST STRIP IN WATER AND THE NITRITE RESULT WAS A FALSELY POSITIVE. THE CUSTOMER STATED THAT THE NITRITES PORTION OF A TEST STRIP THAT HAD NOT BEEN USED APPEARED "PINKISH". THE CUSTOMER STATED THAT THE CALIBRATION WAS ACCEPTABLE. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 27638300 WAS MEASURED ON AN IU URISYS 1800 WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RESULTS FULFILLED THE REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809501 ↗