MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[112865880]
The investigation determined that lower than expected vitros vanc results were obtained from two different non-vitros, biorad quality control fluids when processed on a vitros 5600 integrated system. The definitive assignable cause for this event could not be determined. An issue isolated to the two reagent packs is likely to be a contributing factor. It is possible these reagent packs were contaminated, although, this cannot be confirmed. The qc fluid results indicate the reagent performance is within expectations when the two reagent packs are removed. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with results less than the measuring range for vitros vanc reagent lot 2514-35-6400. Therefore, a systemic reagent issue can be ruled out as a contributing factor. In order to verify the instrument performance, within run marker precision testing was requested, but not provided. Although there is no evidence the instrument is not performing within expectations, the instrument cannot be ruled out as a contributing factor. The assignable cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[112865881]
A customer observed lower than expected vitros vancomycin (vanc) quality control results from two different non-vitros biorad quality control fluids (lot 40950) obtained using a vitros vanc reagent lot 2514-35-6400 when tested on a vitros 5600 integrated system. Biorad liquicheck immunoassay plus control level 2 (lot 40952) vitros vanc results <5, <5, and <5 ug/ml vs. Expected result of 17. 1 ug/ml. Biorad liquicheck immunoassay plus control level 3 (lot 40953) vitros vanc results <5, <5, <5 and <5 ug/ml vs. Expected result of 31. 8 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. There were no patient results reported outside of the laboratory and there was no allegation of actual patient harm as a result of this event. This report is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00019 |
| MDR Report Key | 7637493 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-26 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-06-26 |
| 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 | 2018-06-26 |
| Catalog Number | 6801709 |
| Lot Number | 2514-35-6400 |
| ID Number | 10758750006731 |
| Device Expiration Date | 2018-08-27 |
| 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 | 2018-06-26 |