MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-21 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT 6801042 manufactured by Ortho-clinical Diagnostics.
[3318801]
The customer obtained a non-reproducible, lower than expected vitros myog result (117. 7 vs. Expected results = 142. 0 ng/ml) from a single patient run on the vitros 5600 integrated system following a calibration event. Biased results of the magnitude and direction observed may lead to inappropriate physician action. However, the customer retested the sample on a different analyzer after a successful calibration. There was no report that the affected sample result was reported from the laboratory. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10544026]
The investigation determined that a non-reproducible, lower than expected vitros myog result was obtained from a single patient run on the vitros 5600 integrated system. A definitive root cause for the event could not be determined. However, an instrument related issue or a reagent related issue cannot be ruled out as contributing factors. Acceptable performance was obtained following service actions on the instrument by an ocd field engineer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2013-00074 |
| MDR Report Key | 3015823 |
| Report Source | 05 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-02-21 |
| Date Mfgr Received | 2013-02-22 |
| Device Manufacturer Date | 2012-07-27 |
| Date Added to Maude | 2013-05-22 |
| 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 | 3 |
| 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 | 2013-03-21 |
| Catalog Number | 6801042 |
| Lot Number | 0830 |
| Device Expiration Date | 2013-07-03 |
| 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 | 2013-03-21 |