MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[138166854]
The investigation confirmed that a lower than expected vitros myoglobin (myog) result was obtained from a cliniqa quality control (qc) fluid processed using vitros myog reagent in combination with a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause. However, a possible cause for the lower than expected qc fluid result is a suboptimal calibration event. Qc performance improved after another calibration event was executed. In addition, per a customer communication issued 28 november 2018, calibrators must be left out for a minimum of two hours following reconstitution prior to calibrating. Because the customer could not confirm this protocol was initially followed, pre-analytical fluid handling cannot be ruled out as a cause of this event. The vitros 5600 integrated system was performing as intended and did not likely contribute to the event as within-run precision testing performed by the customer was within acceptable guidelines. Additionally, a reagent issue is not a likely cause of the event as a different vitros 5600 integrated system is running as expected when using the same vitros myog reagent lot. Furthermore, continual tracking and trending of complaints has not identified any signals that show a potential systemic issue with vitros myog reagent lot 1390.
Patient Sequence No: 1, Text Type: N, H10
[138166855]
A customer reported a lower than expected result from a cliniqa quality control (qc) fluid obtained using vitros immunodiagnostics products myoglobin (myog) reagent on a vitros 5600 integrated system. Cliniqa lot 1804042 (l1) vitros myog result of 51. 5 ng/ml vs an expected result of 65. 1 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros myog result was generated from a qc fluid. However, the investigation could not conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2019-00025 |
| MDR Report Key | 8313163 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-01-13 |
| Device Manufacturer Date | 2018-09-04 |
| Date Added to Maude | 2019-02-06 |
| 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 | 2019-02-06 |
| Catalog Number | 6801042 |
| Lot Number | 1390 |
| Device Expiration Date | 2019-08-07 |
| 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 | 2019-02-06 |