MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[96047756]
The investigation confirmed that lower than expected myoglobin results were obtained from a non-vitros quality control fluid using vitros immunodiagnostics products myoglobin reagent pack lot 1280 on vitros 5600 integrated systems s/ns (b)(4). A definitive assignable cause for the event could not be determined. As a within-run precision test of the vitros 5600 integrated systems was not performed, it cannot be confirmed that the instruments were operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the events. The most likely assignable cause for the lower than expected vitros myog qc fluid results using the non-vitros biorad qc fluid lot 23635 is a sub optimal calibration event as re-calibration using the same lot of calibrators has resolved the issue for the customer.
Patient Sequence No: 1, Text Type: N, H10
[96047757]
The customer observed lower than expected myoglobin results obtained from a non-vitros quality control (qc) fluid using vitros immunodiagnostic products myoglobin reagent pack on a vitros 5600 integrated system. Biorad level 1 lot 23635 results 109 and 109 ng/ml versus customer established mean 123 ng/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected and the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number one of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2017-00202 |
| MDR Report Key | 7126082 |
| Date Received | 2017-12-18 |
| Date of Report | 2018-12-17 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2017-12-18 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2017-12-18 |
| Catalog Number | 6801042 |
| Lot Number | 1280 |
| ID Number | 10758750001019 |
| Device Expiration Date | 2018-08-19 |
| 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 | 2017-12-18 |