MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8058232 manufactured by .
[118399842]
The investigation has determined that lower than expected, vitros ckmb results were obtained when testing a vitros isoenzyme performance verifier control on a vitros 5600 integrated system. The definitive assignable cause could not be determined. Historical quality control results indicate that vitros ckmb lot 4932-0216-0281 was not performing as expected in regards to both accuracy and precision at this customer site. Ongoing complaint trending and tracking has not identified any signals of a systemic quality issue associated with vitros ckmb slide lot 4932-0216-0261. Diagnostic within run precision testing was not performed to evaluate the vitros 5600 system performance. Therefore, an unexpected analyzer issue or an issue with vitros ckmb lot 4931-0216-0261 cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[118399843]
A customer obtained lower than expected vitros ckmb quality control results when testing vitros isoenzyme performance verifiers on a vitros 5600 integrated system. Vitros isoenzyme performance verifier i lot r5507 vitros ckmb results of 13. 2, 15. 5 and 16. 0 versus the midpoint of the vitros performance verifier i rom 23 u/l. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The lower than expected vitros ckmb results were obtained when testing a quality control fluid. Ortho has not been made aware of any allegation of patient harm as a result of this event. However, the investigation cannot conclude that patient sample results were not affected during this time or would not be affected if the event were to recur in the future undetected. This report is number one of three mdr? S for this event. Three 3500a forms are being submitted for this event as three ckmb slide lots were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00105 |
| MDR Report Key | 7806903 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2017-04-15 |
| Date Added to Maude | 2018-08-22 |
| 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 | 2018-08-22 |
| Catalog Number | 8058232 |
| Lot Number | 4932-0216-0261 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-22 |