MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[139320477]
The investigation confirmed that lower than expected vitros vanc (vancomycin) and vitros valp (valproic acid) results were obtained from two patient samples and on two levels of non-vitros (biorad) quality control (qc) fluids on a vitros 4600 chemistry system. The investigation was able to determine the assignable cause for the lower than expected vitros vanc and valp results were the reagent packs in use at the time of the event. The lower than expected results were obtained from a single pack of vitros vanc reagent and a single pack of vitros valp reagent. Expected results were obtained after a new, unused pack of vitros vanc and a new, unused pack of vitros valp were placed on the instrument. Although proper reagent handling for both vitros vanc and vitros valp was verified, improper pack handling cannot be ruled out as a possible cause of this event. The assignable cause of what affected the reagent packs in use at the time of the events could not be determined. A diagnostic within run vitros gent (gentamicin) precision test was within ortho guidelines both pre and post service indicating the vitros 4600 chemistry system was performing as expected. An instrument related issue can be ruled out as a contributing factor to the event. Historical qc results indicate that vitros vanc lot 2514-37-6935 and vitros valp lot 2511-26-6892 are performing as intended. A transient issue related to the reagent performance cannot be ruled out as a contributing factor. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros vanc lot 2514 37 6935 or vitros valp lot 2511 26 6892.
Patient Sequence No: 1, Text Type: N, H10
[139320478]
A customer obtained lower than expected vitros vanc (vancomycin) and vitros valp (valproic acid) results from two patient samples and on two levels of non-vitros (biorad) quality control (qc) fluids on a vitros 4600 chemistry system. Patient 1 vitros vanc result <5 ug/ml vs. Expected result of 20. 7 ug/ml. Patient 2 vitros vanc result <5 ug/ml vs. Expected result of 17. 58 ug/ml. Liquicheck immunoassay plus control level 3 (lot 40973) vitros vanc results 9. 0, 8. 6 and 9. 2 ug/ml vs. Expected result of 28. 03 ug/ml. Liquicheck immunoassay plus control level 1 (lot 40971) vitros valp results <10, <10 and <10 ug/ml vs. Expected result of 35. 9 ug/ml. Liquicheck immunoassay plus control level 3 (lot 40973) vitros valp results 51. 5, 53. 0 and 51. 8 ug/ml vs. Expected result of 121. 4 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected patient results were reported from the laboratory, but corrected reports were sent. There were no reports of changes in treatment based on the lower than expected patient results. There was no allegation of actual patient harm as a result of this event. This report is number one of two mdr? S for this event. Two 3500a forms are being submitted for this event as a total of two devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00007 |
| MDR Report Key | 8408060 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2019-03-11 |
| 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 | 2019-03-11 |
| Catalog Number | 6801709 |
| Lot Number | 2514-37-6935 |
| 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 | 2019-03-11 |