MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-12-18 for ABBOTT VANCOMYCIN ASSAY 6E44-21 manufactured by Microgenics Corporation.
[95772464]
Customer reported a discrepant vancomycin patient result of <1. 1 on a patient who was receiving vancomycin. It was retested on other architect in the lab and the result was repeatable, sample repeated in 1:4 dilution and read 14. 4. Sample was aliquoted and sent to a reference lab and was tested by the siemens vanco assay and got a result of 32. 0 ng/ml. The problem started on (b)(6) 2017, customer had 4 random draws and 2 draws were done after medication was given between the dates (b)(6). The same patient draw from (b)(6) 2017 the patient result was 16. 4. No issues with other assays qc all in range and the retest of the proficiency sample produced repeatable results from the original testing. Customer concluded that the sample is the cause of the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010939897-2017-00003 |
| MDR Report Key | 7124396 |
| Report Source | OTHER |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-11-14 |
| Date Mfgr Received | 2017-11-21 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2017-12-18 |
| 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 PATRICK LYNCH |
| Manufacturer Street | 46500 KATO ROAD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5109795000 |
| Manufacturer G1 | MICROGENICS CORPORATION |
| Manufacturer Street | 46500 KATO ROAD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT VANCOMYCIN ASSAY |
| Generic Name | VANCOMYCIN TEST SYSTEM |
| Product Code | LEH |
| Date Received | 2017-12-18 |
| Model Number | 6E44-21 |
| Catalog Number | 6E44-21 |
| Lot Number | 39468FD01 |
| Device Expiration Date | 2018-09-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROGENICS CORPORATION |
| Manufacturer Address | 46500 KATO ROAD FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |