MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[110579077]
The investigation determined that a non-reproducible and higher than expected ckmb result was obtained on a patient sample processed from using vitros ckmb reagent on a vitros 5600 integrated system. The assignable cause of the event is unknown. A review of historical vitros ckmb quality control results, performance testing and data log analysis concluded there was no malfunction of the vitros ckmb reagent or the vitros 5600 system. Repeat testing of all the analytes initially tested on the sample were concordant, with the exception of the vitros ckmb assay. This would indicate that pre-analytical sample mix up did not contribute to the event no information concerning the customer? S pre-analytical centrifugation protocol was provided. Therefore, it is unknown if the centrifugation protocol in use is within the sample collection device manufacture? S centrifugation recommendations. It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[110579078]
The customer observed a non-reproducible and higher than expected ckmb result (19. 2 verses expected 0. 22 ng/ml) from a patient sample processed using vitros ckmb reagent on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The higher than expected vitros ckmb result was reported from the laboratory; however, sample testing was repeated and a corrected report was sent to the physician. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00076 |
| MDR Report Key | 7566429 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-12-22 |
| 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 | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JHX |
| Date Received | 2018-06-04 |
| Catalog Number | 1896836 |
| Lot Number | 2280 |
| ID Number | 10758750000203 |
| Device Expiration Date | 2018-10-19 |
| 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 | 2018-06-04 |