3002769706-2017-00148
Report
- Report Number
- 3002769706-2017-00148
- Event Type
- Injury
- Date Received
- June 23, 2017
- Report Date
- October 11, 2017
- PMA / PMN Number
- K923579
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
DEVICE NOT RETURNED TO MANUFACTURER.
(B)(4). A CUSTOMER FROM THE UNITED KINGDOM HAD CONTACTED BIOMÉRIEUX TO REPORT UNEXPECTED NEGATIVE RESULTS FOLLOWED BY A QCV FAILURE, ON THE B2 POSITION OF THE MINIVIDAS® INSTRUMENT S/N (B)(4). THE CUSTOMER INDICATED THAT THIS ISSUE APPEARED AFTER THE PREVENTIVE MAINTENANCE ON 18MAY2017: ALL TESTS PERFORMED AT THIS POSITION SINCE THEN HAD A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT DUE TO THE NEGATIVE RESULT, A PREGNANT FEMALE HAD BEEN GIVEN VZV IMMUNOGLOBULIN UNNECESSARILY. ON 25MAY2017, A BIOMÉRIEUX SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE IN ORDER TO VERIFY THE SYSTEM. THE FSE NOTICED THAT THE RUBBER SEAL FOR THE AFFECTED POSITION (B2) WAS PARTIALLY FOLDED. THE SEAL WAS REPLACED, AND THE INSTRUMENT WAS CONFIRMED OPERATIONAL AFTER QUALIFYING IT BY PERFORMING A QCV TEST AND LEAK TEST. BIOMÉRIEUX REQUESTED A RETROSPECTIVE ANALYSIS BETWEEN THE DATE OF THE PREVENTIVE MAINTENANCE ON 18MAY2017 AND THE DATE OF THE INTERVENTION OF THE FSE ON 25MAY2017. THE CUSTOMER PERFORMED RETROSPECTIVE ANALYSIS AND IDENTIFIED A TOTAL OF 4 FALSE RESULTS. OF THESE RESULTS, ONLY ONE OF THE FOUR HAD ANY PATIENT IMPACT: TWO OF THESE RESULTS WERE VZV. THE FIRST ONE WAS REPORTED INCORRECTLY: A PREGNANT WOMEN WAS PRESCRIBED VZV ANTIBODY UNNECESSARILY. THIS INCORRECT RESULT WAS THE ONE INITIALLY REPORTED BY THE CUSTOMER. FOR THE SECOND RESULT, THE CUSTOMER INDICATED THAT IT WAS NOT REPORTED TO THE CLINICIAN AND THEREFORE NOT ACTED UPON. THE THIRD WAS A RUBELLA IGG, WHICH WAS ALSO NOT REPORTED. THE FOURTH WAS A TOXO THAT WAS SENT FOR CONFIRMATION AND THEREFORE DID NOT IMPACT THE CLINICAL DECISION BUT MAY HAVE CAUSED A DELAY. INVESTIGATION SHOWED THREE HYPOTHESES: DURING PREVENTIVE MAINTENANCE, FSE DID NOT REPLACE THE SEAL CORRECTLY: THE PROBABILITY IS VERY LOW BECAUSE THE FSE PERFORMED A TP1 AND A LEAK TEST AT THE END OF HIS INTERVENTION WHICH WERE CONFORM. A FOLDED SEAL GENERATES A LEAK, AND THE LEAK TEST SHOULD HAVE DETECTED THIS ISSUE. THE SEAL HAS BEEN FOLDED DURING NORMAL USE OF THE INSTRUMENT DUE TO A DEFECTIVE SEAL: WE CANNOT CONCLUDE ON THIS HYPOTHESIS AS WE DON'T HAVE THE CONCERNED SEAL, BUT THIS REMAINS A POSSIBILITY. THE SPR DOOR WAS OPENED BY OPERATOR DURING ANALYSIS PROCESS: TESTS PERFORMED BY APPLICATION SPECIALIST IN UK SHOWED THAT, IF THE SPR DOOR IS PULLED HARD AT RIGHT TIME DURING THE CYCLE, THE SPR CAN CATCH THE SEALS, AND PULL THEM PARTIALLY THROUGH. THIS REMAINS A POSSIBILITY TOO.
A CUSTOMER FROM (B)(6) HAD CONTACTED BIOMÉRIEUX TO REPORT UNEXPECTED NEGATIVE RESULTS FOLLOWED BY A QCV FAILURE, ON THE B2 POSITION OF THE MINIVIDAS® INSTRUMENT S/N ITV12I3094. THE CUSTOMER INDICATED THAT THIS ISSUE APPEARED AFTER THE PREVENTIVE MAINTENANCE ON (B)(6) 2017: ALL TESTS PERFORMED AT THIS POSITION SINCE THEN HAD A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT DUE TO THE NEGATIVE RESULT, A PREGNANT FEMALE HAD BEEN GIVEN VZV IMMUNOGLOBULIN UNNECESSARILY. ON (B)(6) 2017, A BIOMÉRIEUX SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE IN ORDER TO VERIFY THE SYSTEM. THE FSE NOTICED THAT THE RUBBER SEAL FOR THE AFFECTED POSITION (B2) WAS PARTIALLY FOLDED. THE SEAL WAS REPLACED, AND THE INSTRUMENT WAS CONFIRMED OPERATIONAL AFTER QUALIFYING IT BY PERFORMING A QCV TEST AND LEAK TEST. BIOMÉRIEUX REQUESTED A RETROSPECTIVE ANALYSIS BETWEEN THE DATE OF THE PREVENTIVE MAINTENANCE ON (B)(6) 2017 AND THE DATE OF THE INTERVENTION OF THE FSE ON (B)(6) 2017. THE CUSTOMER PERFORMED RETROSPECTIVE ANALYSIS AND IDENTIFIED A TOTAL OF 4 FALSE RESULTS. OF THESE RESULTS, ONLY ONE OF THE FOUR HAD ANY PATIENT IMPACT: TWO OF THESE RESULTS WERE VZV. THE FIRST ONE WAS REPORTED INCORRECTLY : A PREGNANT WOMEN WAS PRESCRIBED VZV ANTIBODY UNNECESSARILY. THIS INCORRECT RESULT WAS THE ONE INITIALLY REPORTED BY THE CUSTOMER. FOR THE SECOND RESULT, THE CUSTOMER INDICATED THAT IT WAS NOT REPORTED TO THE CLINICIAN AND THEREFORE NOT ACTED UPON. THE THIRD WAS A RUBELLA IGG, WHICH WAS ALSO NOT REPORTED. THE FOURTH WAS A TOXO THAT WAS SENT FOR CONFIRMATION AND THEREFORE DID NOT IMPACT THE CLINICAL DECISION BUT MAY HAVE CAUSED A DELAY. INVESTIGATION SHOWED THREE HYPOTHESES : DURING PREVENTIVE MAINTENANCE, FSE DID NOT REPLACE THE SEAL CORRECTLY: THE PROBABILITY IS VERY LOW BECAUSE THE FSE PERFORMED A TP1 AND A LEAK TEST AT THE END OF HIS INTERVENTION WHICH WERE CONFORM. A FOLDED SEAL GENERATES A LEAK, AND THE LEAK TEST SHOULD HAVE DETECTED THIS ISSUE. THE SEAL HAS BEEN FOLDED DURING NORMAL USE OF THE INSTRUMENT DUE TO A DEFECTIVE SEAL: WE CANNOT CONCLUDE ON THIS HYPOTHESIS AS WE DON'T HAVE THE CONCERNED SEAL, BUT THIS REMAINS A POSSIBILITY. THE SPR DOOR WAS OPENED BY OPERATOR DURING ANALYSIS PROCESS: TESTS PERFORMED BY APPLICATION SPECIALIST IN UK SHOWED THAT, IF THE SPR DOOR IS PULLED HARD AT RIGHT TIME DURING THE CYCLE, THE SPR CAN CATCH THE SEALS, AND PULL THEM PARTIALLY THROUGH. THIS REMAINS A POSSIBILITY TOO.
A CUSTOMER FROM THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT UNEXPECTED NEGATIVE TEST RESULTS FOR ONE OF THE MINIVIDAS® TEST SLOTS. THE CONSISTENTLY NEGATIVE RESULTS OCCURRED FOLLOWING PREVENTIVE MAINTENANCE SERVICE BY A THIRD-PARTY SERVICE VENDOR (ASPECT SCIENTIFIC). A LOCAL BIOMÉRIEUX SERVICE ENGINEER VISITED THE CUSTOMER SITE AND IDENTIFIED THE RUBBER SEAL FOR THE IMPLICATED SLOT WAS NOT SEATED PROPERLY PREVENTING PROPER SAMPLE PIPETTING. REPAIR WAS MADE AND THE INSTRUMENT WAS CONFIRMED OPERATIONAL. INITIAL RETROSPECTIVE ANALYSIS OF PATIENT TEST RESULTS ASSOCIATED WITH THE SLOT INDICATED THAT ONE PATIENT, A PREGNANT FEMALE, WAS GIVEN VZV IMMUNOGLOBULIN UNNECESSARILY DUE TO A FALSE RESISTANT TEST RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE UNNECESSARY VZV IMMUNOGLOBULIN THERAPY LED TO ANY DEGRADATION RELATED TO THE PATIENT'S STATE OF HEALTH; NO FURTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |