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 2018-01-31 for VANCOMYCIN GEN.3 06781632190 manufactured by Roche Diagnostics.
[98979345]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98979346]
The customer stated that they received erroneous results for three samples from the same patient tested for vanc3 vancomycin (vanc) on a cobas 8000 c 702 module (c702). The obtained values were unexpectedly low. It was asked, but it is not known if the erroneous results were reported outside of the laboratory. The first sample resulted with a vanc value of < 4 mg/l when tested on the c702 analyzer. The sample was repeated on an abbott instrument, resulting as 44 mg/l. The sample was also repeated with a lcmsms method, resulting as 38 mg/l. On (b)(6) 2018, the second sample resulted with a vanc value of 0. 0 mg/l when tested on the c702 analyzer. The reaction kinetics of this value appeared to be abnormal, with a strong reaction. The sample was repeated on an abbott instrument, resulting as 63 mg/l. The sample was also repeated with a lcmsms method, resulting as 52 mg/l. On (b)(6) 2018, the third sample resulted with a vanc value of < 4 mg/l when tested on the c702 analyzer. The sample was repeated on an abbott instrument, resulting as 75 mg/l. The sample was also repeated with a lcmsms method, resulting as 63 mg/l. No adverse events were alleged to have occurred with the patient. No issues were seen upon visual inspection of the affected samples. The serum indices of the samples did not indicate an issue. Electrophoresis performed on one of the samples showed a small m-peak in the gamma fraction. The igm result was 3. 57 g/l. Product labeling documents implausible results can be due to interferences caused by a gammopathy. However, as the igm value was only slightly elevated it was unclear if the patient had just inflammation. The serial number of the c702 analyzer was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[134192184]
The investigation was unable to find a definitive root cause. A sample from the patient was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00280 |
| MDR Report Key | 7230745 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-31 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-01-14 |
| Date Mfgr Received | 2018-01-16 |
| Date Added to Maude | 2018-01-31 |
| 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 GEN.3 |
| Generic Name | VANCOMYCIN RADIOIMMUNOASSAY |
| Product Code | LEH |
| Date Received | 2018-01-31 |
| Model Number | NA |
| Catalog Number | 06781632190 |
| Lot Number | 260685 |
| 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 | 2018-01-31 |