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 VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[138669810]
The investigation confirmed that higher than expected vitros vancomycin (vanc) results were obtained from multiple samples collected from the same patient when tested on a vitros 5600 integrated system. The most likely assignable cause of the event is a sample interferent isolated to the affected patient. The patient has an elevated rheumatoid factor (rf) concentration. Representative samples from the patient have been sent to ortho for further investigational testing. The vitros vanc instructions for use does not list rf as an interfering substance. A patient sample correlation, consisting of samples collected from alternate patients, generated concordant results between the vitros and non-vitros (siemens) vancomycin assays, indicating the issue is isolated to the affected patient. There was no indication vitros vanc lot 2514-37-6935 or the vitros 5600 system malfunctioned. Historical quality control results obtained prior to the event were acceptable, indicating the vitros vanc reagent was performing as intended on the vitros 5600 system. Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros vanc lot 2514-37-6935.
Patient Sequence No: 1, Text Type: N, H10
[138669851]
A customer obtained higher than expected vitros vancomycin (vanc) results from multiple samples collected from the same patient when tested on a vitros 5600 integrated system. Patient sample 1 results of 30. 2 and 27. 0 ug/ml vs. The expected result of 7. 4 ug/ml. Patient sample 2 result of 27. 1 ug/ml vs. The expected result of 6. 6 ug/ml. Patient sample 3 result of 28. 3 ug/ml vs. The expected result of 7. 4 ug/ml. Patient sample 4 result of 32. 7 ug/ml vs. The expected result of 9. 0 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros vanc results were reported from the laboratory, however a clinician questioned the results. Corrected reports were issued and no allegation of actual patient harm was made. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00005 |
| MDR Report Key | 8339291 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-08-31 |
| 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 VANC REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LEH |
| Date Received | 2019-02-14 |
| Catalog Number | 6801709 |
| Lot Number | 2514-37-6935 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 |