COBAS 8000 C 502 MODULE
Report
- Report Number
- 1823260-2022-02353
- Event Type
- Malfunction
- Date Received
- August 8, 2022
- Date of Event
- March 21, 2022
- Report Date
- June 26, 2023
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- UDI-DI
- 04015630928354
- PMA / PMN Number
- K100853
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT WAS INITIALLY PROVIDED TO ROCHE BY FDA VIA MEDWATCH 0504410000-2022-8001. THE FIELD SERVICE REPRESENTATIVE FOUND THE ISSUE TO BE CAUSED BY A LEAKING DETERGENT VALVE AND AGED RINSE TUBING. HE REPLACED THE DETERGENT VALVE AND RINSE TUBING. HE PERFORMED A PRECISION CHECK AND CORRELATION TEST ON BOTH LINES. PREVENTATIVE MAINTENANCE WAS PERFORMED. THE CUSTOMER VERIFIED THE DATA AND PERFORMED CALIBRATION AND QC. THE INVESTIGATION IS ONGOING.
THE INVESTIGATION FOUND THE CUSTOMER'S QC TARGET RANGES FOR AMPH AND BARB DID NOT APPEAR TO BE ACCURATE. THE PROVIDED QC DATA SHOWS LEVEL 1 QC AS CONSISTENTLY NEGATIVE AND BELOW THE CUTOFF AND LEVEL 2 QC AS CONSISTENTLY POSITIVE AND ABOVE THE CUTOFF ON THE DAY OF THE EVENT. THE FIELD SERVICE REPRESENTATIVE PERFORMED MECHANICAL CHECKS, CHECKED THE APPLICATION SETTINGS, CHECKED THE ONBOARD STABILITY OF THE REAGENT PACKS, CHECKED THE ONBOARD STABILITY OF THE DETERGENTS AND WASHES FOR THE DRUGS OF ABUSE, AND REVIEWED THE CUSTOMER'S QC AND CALIBRATION REPORT FROM THE LAST 3 MONTHS, WHICH WERE ACCEPTABLE. CALIBRATION AND QC WERE PERFORMED ON THE DRUG OF ABUSE TESTS USING FRESH MATERIAL AND THE RESULTS WERE ACCEPTABLE. THE PRECISION TEST, PERFORMED WITH FRESH MATERIAL, PASSED WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.
THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS DUE TO A MISALIGNED RINSE NOZZLE ON THE RINSE ASSEMBLY AND NOT A CLOG IN THE RINSE NOZZLE OR ISSUES WITH THE VALVE AND TUBING. THE MISALIGNMENT INTERMITTENTLY CAUSED A WATER CARRYOVER EFFECT INTO AN ADJACENT CUVETTE. ADDITIONAL WATER IN DRUGS OF ABUSE REACTIONS CAN CAUSE FALSE POSITIVE RESULTS. THE ISSUE WAS VERY INTERMITTENT AND WAS CORRECTED BY REPLACING THE RINSE ASSEMBLY.
THERE WAS AN ALLEGATION OF FALSE-POSITIVE BARB RESULTS FOR 1 PATIENT SAMPLE AND FALSE-POSITIVE BARB AND FALSE-POSITIVE AMPS2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 502 MODULE. PATIENT 1: (SAMPLE (B)(6): THE INITIAL BARB RESULT WAS POSITIVE (91 MABS). THE REPEATED BARB RESULT WAS NEGATIVE (-546 MABS). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2022 AND THE BARB RESULT WAS NEGATIVE (-535 MABS). PATIENT 2: (SAMPLE (B)(6) THE INITIAL BARB RESULT WAS POSITIVE (21 MABS). THE REPEATED BARB RESULT WAS POSITIVE (26 MABS). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2022 AND THE BARB RESULT WAS NEGATIVE (-505 MABS). THE INITIAL AMPS2 RESULT WAS POSITIVE (74 MABS). THE REPEATED AMPS2 RESULT WAS NEGATIVE (-200 MABS). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2022 AND THE AMPS2 RESULT WAS NEGATIVE (-213 MABS). THE REPEATED RESULTS WERE OBTAINED AFTER CALIBRATION WAS PERFORMED. THE ERRONEOUS RESULTS WERE ALL REPORTED OUTSIDE OF THE LABORATORY. NO PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS, AND CORRECTED REPORTS WERE SENT. THE AMPS2 REAGENT LOT NUMBER IS 54436601 WITH AN EXPIRATION DATE OF 31-JAN-2023. THE BARB REAGENT LOT NUMBER IS 55128101 WITH AN EXPIRATION DATE OF 28-FEB-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370101 | COBAS 8000 C 502 MODULE | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | C502 | NA | 04015630928354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |