MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-08 for VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[5434268]
An ocd laboratory specialist observed a single non-reproducible, higher than expected vitros ckmb result from a non-vitros qc sample processed on a vitros 5600 integrated system. Non-vitros qc sample level 1: vitros ck-mb result of 4. 508 ng/ml vs. Vitros assigned mean of 3. 37 ng/ml. Biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected. No patient samples were affected and there were no allegations of harm as a result of the events described. However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12747807]
The investigation confirmed that a non-reproducible, higher than expected vitros ckmb result was obtained from a non-vitros qc sample processed on a vitros 5600 system. Root cause of the higher than expected qc test result could not be determined, although the investigation could not exclude inappropriate pre-analytical sample handling / storage of the test materials as a possible root cause. The investigation also could not exclude unexpected vitros analyzer or ck-mb product performance as possible contributory factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2015-00007 |
| MDR Report Key | 4398763 |
| Report Source | 05 |
| Date Received | 2015-01-08 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-11 |
| Device Manufacturer Date | 2014-05-06 |
| Date Added to Maude | 2015-01-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2015-01-08 |
| Catalog Number | 1896836 |
| Lot Number | 1690 |
| Device Expiration Date | 2015-03-03 |
| 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 | 2015-01-08 |