MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[110584655]
The investigation determined that a higher than expected results were obtained from lithium heparin plasma samples obtained from a whole blood pool, when compared to vitros crbm results obtained from serum samples obtained from the same whole blood pool. Vitros na heparin plasma results were also higher than expected but did not exceed potential health and safety criteria. The higher than expected vitros crbm results were obtained from three different vitros crbm slide lots tested on a vitros 5600 integrated system. The most likely assignable cause of the higher than expected vitros crbm results could not be determined. A total of 71 sample sets were processed to compare crbm results generated from plasma (li and na heparin) to serum values. Li and na heparin results obtained from 70 of the 71 sample sets were comparable to the serum results, with only the affected sample set identified in this issue generating higher than expected li heparin plasma results. Therefore, a positive bias associated with plasma versus serum samples did not likely contribute to the event. In addition, there was no indication the vitros crbm slides or the vitros 5600 system malfunctioned. Quality control testing was performed at the beginning and end of each test event and the results were within the expected intervals. In addition, the vitros 5600 integrated system was qualified per internal ortho procedures indicating the system was operating as expected. Finally, no pre-analytical user error involving sample processing was identified.
Patient Sequence No: 1, Text Type: N, H10
[110584656]
A customer reported higher than expected vitros crbm results were obtained from lithium heparin plasma samples obtained from a whole blood pool, when compared to vitros crbm results obtained from serum samples obtained from the same whole blood pool. The higher than expected vitros crbm results were obtained from three different vitros crbm slide lots tested on a vitros 5600 integrated system. Slide lot 3939-0100-5621: li heparin plasma vitros crbm result of 17. 3 ug/ml versus the expected result 12. 7 ug/ml. Slide lot 3940-0101-6816: li heparin plasma vitros crbm result of 19. 5 ug/ml versus the expected result 12. 7 ug/ml. Slide lot 3942-0102-6251: li heparin plasma vitros crbm result of 18. 9 ug/ml versus the expected result 13. 0 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were affected as the testing was internal to ortho, however; the investigation cannot conclude that patient sample results could not be affected or would not be affected if the event were to recur undetected in a health care setting. There was no report of patient harm as a result of this event. This report is number three of three 3500a forms filed for this event, as three devices were affected. This report corresponds to ortho clinical diagnostics inc. Non conformance (b)(64.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00088 |
| MDR Report Key | 7567466 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2018-03-13 |
| Date Added to Maude | 2018-06-04 |
| 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 | 2018-06-04 |
| Catalog Number | 8892382 |
| Lot Number | 3942-0102-6251 |
| ID Number | 10758750005185 |
| Device Expiration Date | 2018-08-01 |
| 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 | 2018-06-04 |