MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[100894344]
The investigation determined that lower than expected, vitros myog results were obtained from a non-vitros quality control fluid when tested on a vitros 5600 integrated system. A definitive assignable cause could not be determined. The most likely assignable cause for the lower than expected qc fluid results is a sub optimal calibration event. In addition, an instrument maintenance issue may have contributed to the event as the customer had not performed cleaning of the microwell incubator as per the recommended schedule.
Patient Sequence No: 1, Text Type: N, H10
[100894345]
A customer obtained lower than expected vitros myoglobin (myog) results when processing a non-vitros quality control fluid on a vitros 5600 integrated system. Biorad level 1 lot 29861 vitros myog results 55. 052*, 56. 154*,45. 488*, and 52. 546* ng/ml versus the baseline mean 66. 39 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The lower than expected, vitros myog results were obtained when processing a quality control fluid. Ortho was not made aware of any allegation of patient harm as a result of this 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00018 |
| MDR Report Key | 7282173 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-01-21 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2018-02-20 |
| 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 DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2018-02-20 |
| 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 | 2018-02-20 |