MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-11 for VITROS IMMUNODIAGNOSTICS PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[4993122]
The customer obtained non-reproducible vitros ck-mb quality control results (cliniqa l1= 5. 07 vs. Expected 3. 17 ng/ml) 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 on patient samples. There was no report of affected vitros ck-mb patient sample results. There was no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12468465]
The investigation determined that a higher than expected non-reproducible vitros ck-mb quality control result was obtained on a vitros 5600 integrated system. There was no evidence that a reagent issue or an instrument issue contributed to the event. The assignable cause of this event is unknown. However, pre-analytical quality control sample handling or atypical calibration, potentially related to the set of calibrators in use, could not be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2014-00248 |
| MDR Report Key | 4244122 |
| Report Source | 05 |
| Date Received | 2014-11-11 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2014-10-13 |
| Device Manufacturer Date | 2014-05-06 |
| Date Added to Maude | 2014-11-24 |
| 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 PRODUCTS CK-MB REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JHX |
| Date Received | 2014-11-11 |
| 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 | 2014-11-11 |