MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-11 for VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[5412127]
A customer complained that a lower than expected vitros ck-mb result was obtained from a patient sample when processed on a vitros 5600 integrated system. Vitros ck-mb patient result 3. 18 ng/ml vs. Expected 5. 13 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action. The lower than expected patient sample result was not reported from the laboratory and there was no allegation of harm as a result of the event 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. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12858719]
The investigation confirmed that a lower than expected vitros ck-mb result was obtained from a patient sample when processed on a vitros 5600 integrated system. Root cause for the event could not be determined; however, the investigation could not exclude an unexpected vitros analyzer issue or a sub-optimal calibration event as possible contributing factors. There was no indication that a vitros ck-mb reagent had contributed to the event
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2015-00028 |
| MDR Report Key | 4506636 |
| Report Source | 05 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-02-11 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-01-13 |
| Device Manufacturer Date | 2014-09-16 |
| Date Added to Maude | 2015-03-18 |
| 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 | 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 | 2015-02-11 |
| Catalog Number | 1896836 |
| Lot Number | 1730 |
| Device Expiration Date | 2015-07-17 |
| 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 | 2015-02-11 |