MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-17 for VANCOMYCIN 04491050190 manufactured by Roche Diagnostics.
[106249760]
(b)(4). The customer discarded the reagent pack.
Patient Sequence No: 1, Text Type: N, H10
[106249761]
The customer initially complained that a reagent pack for vanc2 vancomycin (vanc2) would not hold a calibration on the cobas 6000 c (501) module. The customer calibrated on (b)(6) 2018 but qc results were out of the acceptable range on (b)(6) 2018. After recalibrating on (b)(6) 2018, qc results were back within the acceptable range. On (b)(6) 2018 qc was out of the acceptable range again. The customer disposed of the vanc2 reagent pack and replaced it with a new one from the same lot and qc results were acceptable. The customer complained that discrepant results were obtained for 3 patient samples tested on the reagent pack that had been discarded. Patient 1 initial vanc2 result was < 1. 7 ug/ml. The sample was repeated on the same c501 module and the result was 5. 0 ug/ml. Patient 2 initial vanc2 result was < 1. 7 ug/ml. The sample was repeated on the same c501 module and the result was 6. 0 ug/ml. Patient 3 initial vanc2 result was 3. 5 ug/ml. The sample was repeated on the same c501 module and the result was 8. 0 ug/ml. The incorrect results were reported outside of the laboratory. The repeat results were believed to be correct. No adverse event occurred. The c501 module serial number was (b)(4). The customer declined a service visit since the new vanc2 reagent pack worked fine. The customer thinks the issue was due to a "bad" reagent pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01189 |
| MDR Report Key | 7436210 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-17 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-04-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2018-04-17 |
| Model Number | NA |
| Catalog Number | 04491050190 |
| Lot Number | 30752701 |
| ID Number | NA |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-17 |