MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-03 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT 6801042 manufactured by Ortho-clinical Diagnostics.
[3010577]
A customer observed lower than expected vitros myoglobin quality control results on a vitros 5600 system. Vitros myoglobin results of 62. 6, 65 vs expected result=95 ng/ml were obtained from the biorad level i control fluid. Vitros myoglobin result of 116. 77 ng/ml vs. Expected result= 166 ng/ml was obtained from the biorad level ii control fluid. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Unexpected patient sample results were not obtained as a result of this event and there was no report of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10211420]
The investigation confirmed that a customer observed lower than expected vitros myoglobin quality control results on a vitros 5600 system. There is no evidence to suggest that the reagent lot in use contributed to the event. An ocd field engineer performed service actions to several analyzer subsystems. It is unknown if the service actions performed were related to the event. Root cause of the event could not be determined. However, pre-analytical sample preparation and/or an analyzer related event cannot be ruled out as contributing factors. Information regarding the occupation of the complainant is unavailable at the time of filing of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2012-00183 |
| MDR Report Key | 2770986 |
| Report Source | 05 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-04 |
| Date Mfgr Received | 2012-09-04 |
| Device Manufacturer Date | 2011-11-18 |
| Date Added to Maude | 2013-01-22 |
| 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. JOSEPH FALVO |
| 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 IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2012-10-03 |
| Catalog Number | 6801042 |
| Lot Number | 0780 |
| Device Expiration Date | 2012-11-02 |
| 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 | 2012-10-03 |