MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5 1149764 manufactured by Ortho-clinical Diagnostics.
[131920479]
The investigation determined that lower than expected results were obtained from both a vitros quality control (qc) fluid and a non-vitros qc fluid using vitros chemistry products amon slides on a vitros 5600 integrated system. The investigation concluded that the most likely assignable cause was a calibration issue. The original calibration parameters were reviewed and deemed to be atypical. The calibrator values all appeared similar to each other, but were very high compared to average. After a new calibration event was executed using a fresh set of calibrators and a fresh vitros amon slide cartridge, both from the same lot, results were attained that were within expectations. The reagent performance after the new calibration was comparable to expectations. Therefore, the reagent can be ruled out as a contributing factor to the event. Furthermore, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros amon reagent lot 1018-0250-2979. Performance testing to verify the instrument was not completed. Although the instrument was not verified, there is no indication that the instrument contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[131920480]
A customer reported lower than expected quality control (qc) results obtained from both vitros liquid performance verifier (pv) fluids and non-vitros quality control fluids using vitros chemistry products amon slides in combination with a vitros 5600 integrated system. Vitros liquid performance verifier ii lot g6496 result of <9 umol/l vs the expected result of 197. 2 umol/l non-vitros mas quality control fluid result of <9 umol/l vs the expected result of 148 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected results were attained from qc fluids. There were no reports of affected patient results and there were no allegations of patient harm. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00048 |
| MDR Report Key | 8178630 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-24 |
| Date Mfgr Received | 2018-11-25 |
| Device Manufacturer Date | 2018-03-30 |
| Date Added to Maude | 2018-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5 |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | CIX |
| Date Received | 2018-12-19 |
| Catalog Number | 1149764 |
| Lot Number | 0528 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |