MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for VITROS CHEMISTRY PRODUCTS TOBRA REAGENT 6801712 manufactured by Ortho-clinical Diagnostics.
[139090069]
The investigation concluded that higher than expected vitros tobramycin (tobra) results were obtained from a high level calibrator fluid processed using a vitros 5600 integrated system. A definitive root cause could not be determined. The calibrator fluid was diluted and tested as part of an investigation for an issue with high diluted tobra results on multiple cap proficiencies. The higher than expected results for diluted samples have occurred across multiple vitros tobra lots of reagent over time. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros tobra reagent lot 1513-03-5038. The assignable cause is not likely to be related to a specific reagent lot or calibration event. An instrument issue or an issue related to the on-board dilution cannot be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[139090070]
A customer obtained higher than expected vitros tobramycin (tobra) results from a high level calibrator fluid processed using a vitros 5600 integrated system. Calibrator kit lot 1428, bottle 6 results 14. 0, 14. 3 ug/ml versus an expected result of 10. 4, 10. 6 ug/ml. No erroneous patient sample results were obtained or reported from the laboratory. However, the investigation cannot definitively 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 actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00006 |
| MDR Report Key | 8339392 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-05-17 |
| Date Added to Maude | 2019-02-14 |
| 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LDO |
| Date Received | 2019-02-14 |
| Catalog Number | 6801712 |
| Lot Number | 1513-05-6924 |
| Device Expiration Date | 2019-11-17 |
| 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 | 2019-02-14 |