MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-04-20 for VANCOMYCIN 06779336190 manufactured by Roche Diagnostics.
[106270769]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[106270770]
The customer complained of questionable low vanc3 vancomycin (vanc3) results for 1 patient tested on a cobas 8000 c 502 module compared to abbott architect. The patient had 4 separate sample that were tested on both the cobas c502 and the abbott architect. For sample 1 the cobas c502 result was < 4 mg/l. The abbott architect result for sample 1 was about 20 mg/l. For sample 2 on (b)(6) 2018 the cobas c502 result was < 4 mg/l. The abbott architect result for sample 2 was about 20 mg/l. For sample 3 on (b)(6) 2018 the cobas c502 result was < 4 mg/l. The abbott architect result for sample 3 was about 20 mg/l. For sample 4 on (b)(6) 2018 the cobas c502 result was 39 mg/l. The abbott architect result for sample 4 was about 80 mg/l. The cobas c502 results were released outside of the laboratory, but were considered not believable as the patient was being administered vancomycin. There was no allegation of an adverse event. No treatment was administered based on the cobas c502 results. The cobas c502 serial number was (b)(4). Interference in the sample was suspected. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01231 |
| MDR Report Key | 7446250 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-20 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-04-20 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANCOMYCIN |
| Generic Name | RADIOIMMUNOASSAY, VANCOMYCIN |
| Product Code | LEH |
| Date Received | 2018-04-20 |
| Model Number | NA |
| Catalog Number | 06779336190 |
| Lot Number | 260684 |
| ID Number | NA |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-20 |