MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8058232 manufactured by Ortho-clinical Diagnostics.
[143998399]
The investigation determined that lower than expected vitros ck-mb results were obtained from multiple patient samples when run on a vitros 5600 integrated system. The results were considered lower compared to results obtained from the same samples tested using a non-vitros analyzer. The investigation was unable to determine the assignable cause of the event. The ortho technical solution center (tsc) was unable to obtain any other assay results or any specific clinical information regarding the patients. However, the customer reported the vitros ckmb results do not match the patient diagnosis. The tsc was unable to obtain any details regarding the pre-analytical sample collection, handling and storage of the samples used in the comparison and therefore, pre-analytical sample handling cannot be ruled out as a potential contributing factor. A review of quality control results for the month of february 2019 concluded that the performance of the vitros performance verifiers was acceptable; however, the quality control fluids were only processed 5-6 times the entire month of february. There are not enough qc data points processed in february 2019 to truly access the overall performance of the assay and therefore a ckmb lot 4940-0221-7109 issue cannot be ruled out as a contributing factor to this event. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this lot of vitros ckmb slides. The tsc requested the customer process within run precision testing to confirm performance of the reagent and the analyzer. The precision testing has not been completed at this time and an instrument issue cannot be ruled out as a contributor to this event.
Patient Sequence No: 1, Text Type: N, H10
[143998400]
A customer obtained lower than expected vitros ck-mb results from multiple patient samples run on a vitros 5600 integrated system. The results were considered lower compared to results obtained from the same samples tested using a non-vitros analyzer. Sample 2 vitros = 5 u/l versus abbott architect 54 u/l. Sample 4 vitros = <3 u/l versus abbott architect 38 u/l. Sample 5 vitros = <3 u/l versus abbott architect 44 u/l. Sample 6 vitros = <3 u/l versus abbott architect 79 u/l. Sample 7 vitros = <3 u/l versus abbott architect 29 u/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros ck-mb results were not reported from the laboratory. There was not allegation of actual patient harm as a result of this event. This report is number five of five mdr? S for this event. Five 3500a forms are being submitted for this event as a total of five 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 | 1319809-2019-00021 |
| MDR Report Key | 8470439 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-01-27 |
| Date Added to Maude | 2019-04-01 |
| 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 | 2019-04-01 |
| Catalog Number | 8058232 |
| Lot Number | 4940-0221-7109 |
| Device Expiration Date | 2019-07-01 |
| 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 | 2019-04-01 |