MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8058232 manufactured by Ortho-clinical Diagnostics.
[120712231]
The investigation determined that lower than expected vitros ckmb results were obtained when testing a single level of an unknown quality control fluid on a vitros 350 chemistry system. The definitive assignable cause of the lower than expected vitros ckmb results could not be determined. The control fluid the customer is using for routine vitros ckmb quality control testing was not provided; therefore it was not possible to verify performance for both accuracy and precision. In addition, no information was provided concerning the customer's fluid handling protocols. Therefore, it is possible the affected results are due to a pre-analytical sample handling issue, but this could not be confirmed with the information provided. Diagnostic within run precision testing was not performed to evaluate the vitros 350 system performance. Therefore an unexpected analyzer issue or an issue with vitros ckmb cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[120712232]
The customer observed negatively biased quality control results processed using vitros ckmb slides on a vitros 350 chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected. There was no report of patient harm as a result of this event. Unknown quality control fluid, vitros ckmb results 7. 6 and 14. 7 u/l versus the calculated mean 23. 6 u/l. This report is number one of two 3500a forms filed for this event, as two devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00109 |
| MDR Report Key | 7862168 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-10 |
| 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 CKMB SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHS |
| Date Received | 2018-09-10 |
| Catalog Number | 8058232 |
| Lot Number | NOT PROVIDED |
| 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 | 2018-09-10 |