AlinIQ 03R89-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740145118), received between Apr 29, 2020 and Dec 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED THAT THE ALINIQ AMS (ANALYZER MANAGEMENT SYSTEM) SPE RULE IS NOT BLOCKING TESTS UPDATED BY QPL RULES RESULTING IN PATIENT SAMPLES BEING REPORTED INCORRECTLY. THE SPE ERRORS ARE CAUSING INCORRECT RESULTS TO BE CALCULATED AND AUTO-VALIDATED. THE ERROR IS CAUSING QUALITATIVE INTERPRETATIVE RESULTS TO BE INCORRECTLY CALCULATED AS QNDET AND THEN AUTO-VALIDATED. THE CUSTOMER PROVIDED THE FOLLOWING TWO PATIENT SID EXAMPLES: (B)(6). NO SPECIFIC PATIENT DATA WAS PROVIDED. THE CUSTOMER REQUESTED THAT A RULE BE PUT IN PLACE TO BLOCK ALL RESULTS ON A SAMPLE WHEN ANY TEST ON THE SAMPLE HAS AN SPE ERROR. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369577 ↗
• MalfunctionMar 2, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED NTPRO BNP > LINEARITY RESULTS REPORTED ON ALINIQ AMS SOFTWARE FOR ONE PATIENT. CONFIGURATION RULE WRITTEN BY ABBOTT SHOULD HAVE HELD RESULT SINCE > LINEARITY AND REPORTED OUT SUBSEQUENT DILUTED RESULT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = BNP >4130 RESULT AFTER DILUTION = 5580.1 NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469547 ↗
• MalfunctionNov 28, 2022Computer Software Problem; Computer Software Problem

  THE CUSTOMER EXPERIENCED A DELAY IN REPORTING PATIENT RESULTS (HBCORE AND HCV-II) DUE TO THE CUSTOMER'S LIS NOT RECEIVING DATA FROM THE ALINIQ AMS. IT WAS DISCOVERED THAT THE ALINIQ AMS WAS UNABLE TO TRANSFER THE RESULTS BECAUSE THE CPU WENT OUT. FIELD SERVICE HAD TO RESET THE AMS SERVER TO RESOLVE THE ISSUE. THE CUSTOMER STATED THAT DUE TO HCV-II RESULTS BEING DELAYED APPROXIMATELY 24 HOURS, TRANSFUSION OF BLOOD PRODUCT WAS DELAYED TO ONE PATIENT. IT IS UNKNOWN WHAT TYPE OF BLOOD PRODUCT, PATIENT DIAGNOSIS OR WHETHER THERE WAS ANY PATIENT HARM DUE TO THE DELAY. NO ADDITIONAL PATIENT DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874719 ↗
• MalfunctionOct 12, 2022Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED A DELAY IN REPORTING AN ABNORMAL HIGH SENSITIVE TROPONIN RESULT ON AN 88-YEAR-OLD MALE WAS DUE TO THE ALINIQ AMS SOFTWARE. UPON INFORMING THE BIOLOGIST AT HOSPITAL IN (B)(6) OF THE TROPONIN RESULT, THE CUSTOMER WAS INFORMED THE PATIENT HAD PASSED AWAY. THE PATIENT WAS PRESENT AT (B)(6) SITE FOR AN EMERGENCY ON (B)(6) 2022. BLOOD WORK WAS PERFORMED AT THIS SITE BUT THERE WAS NO ORDER FOR TROPONIN. ON (B)(6) 2022, THE PATIENT WAS TAKEN TO THE HOSPITAL IN (B)(6) AND TWO BLOOD SAMPLES WERE COLLECTED AND SENT TO (B)(6) (MAIN SITE WITH THE TRACK). THE TWO SAMPLE TUBES WERE FOR HIGH SENSITIVE TROPONIN AND D-DIMER. THE ORDERS WERE PLACED IN THE ALINIQ AMS SOFTWARE ON (B)(6) 2022 AT 9:25 AM. THE BLOOD SAMPLES WERE PLACED ONTO THE TRACK AT 11:58 AM ON (B)(6) 2022 AND THE HIGH SENSITIVE TROPONIN RESULT OF 647.90 NG/L WAS GENERATED AND PRESENT IN THE ALINIQ AMS SOFTWARE AT 12:17 PM ON (B)(6) 2022. DUE TO THE ELEVATED HIGH SENSITIVE TROPONIN RESULT, THE LABORATORY TECHNICIAN NEEDED TO VALIDATE THE RESULT IN THE ALINIQ AMS SOFTWARE SO THAT THE ELEVATED HIGH SENSITIVE TROPONIN RESULT CAN BE RELEASE TO THE LIS. IN THE ALINIQ AMS SOFTWARE, THE CUSTOMER HAD SETUP A FILTER PAGE (G

  Patient problems: Insufficient Information

  MAUDE report 15587518 ↗
• MalfunctionApr 29, 2020Patient Data Problem; Patient Data Problem

  ADDITIONAL EVENT DETAILS WERE PROVIDED BY THE CUSTOMER. TECHNICAL DETAILS: THE OSMOLALITY IN URINE REPRESENTS THE NUMBER OF SOLUTES IN A GIVEN AMOUNT OF WATER. A HIGH OSMOLALITY URINE INDICATES A LARGE AMOUNT OF DISSOLVED OSMOTIC PARTICLES AND SUGGESTS THAT THE URINE IS CONCENTRATED. TO OPTIMIZE THE LOGISTICS SURROUNDING THE MEASUREMENT OF THE OSMOLALITY IN URINE, WE CHOSE, TOGETHER WITH OUR CLINICAL PARTNERS, TO FIRST CALCULATE AND REPORT AN ESTIMATED OSMOLALITY, BASED ON THE SODIUM AND UREA MEASUREMENTS. THE ACTUAL MEASUREMENT OF THE URINE OSMOLALITY IS PERFORMED AT A LATER TIME. THIS IS QUICK AND CONVENIENT AS THE SODIUM AND UREA CONCENTRATIONS CAN BE AUTOMATICALLY DETERMINED ON OUR 24-HOUR CHEMISTRY ANALYZERS, WHEREAS AN OSMOLALITY MEASUREMENT REQUIRES A SEPARATE LABORIOUS WORKFLOW (MANUAL MEASUREMENT) AND THE RESPONSE TIME IS LONGER. THE INTERPRETATION AND FOLLOW-UP OF THE ESTIMATED (INDICATIE OSMOL) IS AS FOLLOWS: WHEN THE ESTIMATED OSMOLALITY EXCEEDS 100 MOSMOL/KG, THE CLINICIANS CAN CONCLUDE THAT THE URINE IS CONCENTRATED AND THE ACTUAL MEASUREMENT OF THE OSMOLALITY CAN WAIT AND IS PERFORMED THE NEXT DAY. ALTERNATIVELY, WHEN THE ESTIMATED OSMOLALITY IS BELOW 100 MOSMOL/KG,

  Patient problems: Heart Failure

  MAUDE report 10009787 ↗