MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for VITROS CHEMISTRY PRODUCTS TOBRA REAGENT 6801712 manufactured by Ortho-clinical Diagnostics.
[49786159]
The investigation determined that a higher than expected tobra quality control result was obtained from a non-vitros quality control fluid using vitros tobra reagent with a vitros 5600 integrated system. A definitive assignable cause could not be determined. Vitros gent and alt precision testing of the vitros 5600 integrated system was within acceptance limits, indicating that the vitros 5600 integrated system was operating as intended. However precision testing was performed following replacement of a component, therefore unexpected instrument performance cannot be entirely ruled out as contributing to the event. Historical quality control data was atypical, indicating that a vitros tobra reagent issue cannot be ruled out as a contributing factor. Pre? Analytical handling of the non-vitros qc fluid also could not be ruled out as contributing to the events as information regarding handling protocols was not provided.
Patient Sequence No: 1, Text Type: N, H10
[49786160]
A customer obtained a higher than expected tobramycin (tobra) quality control result (>10. 0 ug/ml versus expected result of 6. 43 ug/ml) from a non-vitros quality control fluid using vitros tobra reagent with a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected tobra results were generated from a non-patient fluid and no erroneous patient sample results were obtained or reported from the laboratory, however the investigation cannot conclude that patient sample results would not be affected if the event were to occur undetected. There is no allegation of patient harm as a result of the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2016-00013 |
| MDR Report Key | 5777200 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-06-12 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2016-03-14 |
| Date Added to Maude | 2016-07-07 |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| 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 | 2016-07-07 |
| Catalog Number | 6801712 |
| Device Expiration Date | 2017-06-10 |
| 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 | 2016-07-07 |