MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[76054065]
The investigation determined that lower than expected myog quality control results were obtained using a non-vitros quality control fluid in combination with a vitros 5600 integrated system. A definitive assignable cause was not determined. The most likely assignable cause for the lower than expected myog results is an issue with a non-vitros bio rad qc fluid. There is no indication that the vitros 5600 integrated system or the vitros myog reagent malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[76054066]
The customer observed lower than expected vitros myog results obtained from non-vitros bio rad quality control fluids processed on a vitros 5600 integrated system. Vitros myog results of 106. 8, 108. 4 and 106. 997 ng/ml versus the peer group mean of 121. 7 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the event, however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2017-00065 |
| MDR Report Key | 6587573 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2017-01-04 |
| Date Added to Maude | 2017-05-24 |
| 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 | 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 MYOGLOBIN REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | DDR |
| Date Received | 2017-05-24 |
| Catalog Number | 6801042 |
| ID Number | 10758750001019 |
| Device Expiration Date | 2017-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-05-24 |