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 2018-08-08 for VANCOMYCIN manufactured by Roche Diagnostics.
[116915946]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[116915947]
The customer stated that they received an erroneous result for one patient sample tested for vanc3 vancomycin on a cobas 6000 c (501) module - c501. The patient did not have any known gammopathy. The sample initially resulted with a vanc3 value of 124. 1 ug/ml accompanied by a data flag. The sample was diluted 1:3 and repeated, resulting with a raw value of 32. 6 ug/ml which calculated to a final value of 97. 8 ug/ml when accounting for the dilution factor. The sample was also diluted 1:3 and repeated a second time, resulting with a raw value of 30. 9 ug/ml which calculated to a final value of 92. 7 ug/ml when accounting for the dilution factor. The 92. 7 ug/ml value was reported outside of the laboratory. The biologist was surprised by the high value as the patient's vancomycin medication (2500 mg. ) was stopped on (b)(6) 2018. He asked for the sample to be repeated at a second laboratory. The sample was repeated at the second laboratory on a siemens dimension analyzer on (b)(6) 2018, resulting as 0. 9 mg/l. No adverse events were alleged to have occurred with the patient. The c501 analyzer serial number was (b)(6). All levels of quality controls were within range for the month of july. Calibration signals for the last calibration performed on (b)(6) 2018 were consistent. A general issue with the reagent and instrument could be excluded as calibration and quality controls were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02641 |
| MDR Report Key | 7762047 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-08 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-08-08 |
| 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 | 2018-08-08 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 290451 |
| 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 | 2018-08-08 |