MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[133841355]
The investigation determined that higher than expected vitros carbamazepine (crbm) results were obtained from a single non-vitros (biorad) control tested on a vitros 5600 integrated system. The assignable cause of the event is unknown, but is not likely a calibration driven event. The higher than expected results were generated from a calibration event that occurred on (b)(6) 2018, however, the event did not occur until (b)(6) 2018. Acceptable results were obtained for the timeframe of (b)(6) 2018. A fluid or vitros crbm slide related issue is unlikely as acceptable results were obtained on an alternate vitros 5600 system on site using the same lot of vitros crbm slides and biorad controls. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros product crbm slides, lot 3943-0103-2834. An instrument related issue did not likely contribute to the event as a vitros crbm within-run precision test, used to assess the performance of the vitros immunorate subsystem of the vitros 5600 system, generated acceptable results.
Patient Sequence No: 1, Text Type: N, H10
[133841356]
A customer obtained higher than expected vitros carbamazepine (crbm) results from a single non-vitros (biorad) control tested on a vitros 5600 integrated system. Biorad level 3 (l3) crbm result of 18. 3 and >20. 0 ug/ml vs. The expected result of 11. 1 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros crbm results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report is number 2 of 2 mdrs for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00002 |
| MDR Report Key | 8229104 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2018-09-06 |
| Date Added to Maude | 2019-01-08 |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CRBM SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | KLT |
| Date Received | 2019-01-08 |
| Catalog Number | 8892382 |
| Lot Number | 3943-0103-2834 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2019-01-08 |