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 2018-03-07 for VANCOMYCIN 06779336190 manufactured by Roche Diagnostics.
[102122412]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102122413]
The customer stated that they received erroneous results for one patient sample tested with vanc2 vancomycin (vanc2) and vancomycin gen. 3 (vanc3) on a cobas 6000 c (501) module - c501. The values measured with each assay did not compare to each other and both values did not compare to the value obtained with the abbott architect vancomycin method. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. (b)(6). The sample resulted as 11. 9 ug/ml when tested with the vanc2 assay and 0. 0 ug/ml when tested with the vanc3 assay. When tested on the abbott architect analyzer, the vancomycin result was 6. 6 ug/ml. No adverse events were alleged to have occurred with the patient. The serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[117887591]
The patient sample was requested for investigation where it was tested for vanc3 on a c501 analyzer, resulting as 1. 49 ug/ml. To rule out the presence of a heterophilic antibody, monoclonal antibody ply mak33 sq was added to the sample and vanc3 testing was repeated. The treated sample resulted with a vanc3 value of 0. 89 ug/ml, suggesting the presence of heterophilic antibodies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00685 |
| MDR Report Key | 7320456 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-07 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-02-15 |
| Date Added to Maude | 2018-03-07 |
| 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 | 2018-03-07 |
| Model Number | NA |
| Catalog Number | 06779336190 |
| Lot Number | 276449 |
| ID Number | NA |
| 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 | 2018-03-07 |