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 2018-09-13 for VANCOMYCIN 06779336190 manufactured by Roche Diagnostics.
[120107788]
Patient Sequence No: 1, Text Type: N, H10
[120107829]
The customer stated that they had questionable results for an unspecified number of patient samples tested for vanc2 vancomycin on a cobas 6000 c (501) module. The customer provided data for one patient sample which had an erroneous vanc2 result that was reported outside of the laboratory. A first sample was collected from the patient and this resulted with a vanc2 value of 0. 0 ug/ml. The customer re-centrifuged this first sample and repeated it, resulting with a vanc2 value of 0. 0 ug/ml. The customer then requested a second sample to be collected from the patient. The second sample initially resulted with a vanc2 value of 0. 0 ug/ml. This sample was then re-centrifuged and repeated, resulting with a vanc2 value of 0. 0 ug/ml. The customer reported a value of less than 1. 7 ug/ml outside of the laboratory to the floor. This second sample was repeated on (b)(6) 2018, resulting with a value of 17. 9 ug/ml. The value of 17. 9 ug/ml was believed to be correct and this value fit the clinical picture of the patient. No adverse events were alleged to have occurred with the patient. The c 501 analyzer serial number is (b)(4). The field service engineer determined that the issue was related to the reagent pack that was used. The customer changed the reagent pack. The customer calibrated the new pack, and then ran controls. The customer had no further issues after doing this. The engineer checked the analyzer and adjusted the rinse water level in the cuvettes. The customer performed maintenance on the analyzer, including replacing the cells and lamp. The engineer verified operation of the analyzer and ran precision studies. The customer ran controls and verified these results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03114 |
| MDR Report Key | 7872103 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-13 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-08-25 |
| Date Mfgr Received | 2018-08-26 |
| Date Added to Maude | 2018-09-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-09-13 |
| Model Number | NA |
| Catalog Number | 06779336190 |
| Lot Number | 29045101 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2018-09-13 |