MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-05-13 for LITHIUM 04679598190 manufactured by Roche Diagnostics.
[1981340]
The customer experienced an ongoing issue with questionable lithium results from the cobas 6000 c501 module, (b)(4), since (b)(6) 2011. Data was provided for three patient samples, of which the results for two were discrepant. Patient sample 1 initial lithium result was 1. 70 mmol/l. The sample was repeated three times with results of 0. 68, 0. 66, and 0. 64 mmol/l. All results were accompanied by data flags. On (b)(6) 2011, patient sample 2 initial lithium result was 1. 70 mmol/l. The sample was repeated three times with results of 0. 75, 0. 76, and 0. 76 mmol/l. All results were accompanied by data flags. It is unknown which results, if any, were reported outside the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[9019418]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6). Precision checks were performed with the %cv within specifications. The gear pump pressure was checked and found to be on the low side. It was adjusted to within specifications.
Patient Sequence No: 1, Text Type: N, H10
[9110008]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6). Other: na.
Patient Sequence No: 1, Text Type: N, H10
[10688308]
A specific root cause could not be determined. There was no evidence of sample or reagent carryover. No application or reagent related issue could be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02602 |
| MDR Report Key | 2088566 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-13 |
| Date of Report | 2013-05-06 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2011-04-15 |
| Date Added to Maude | 2011-05-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHIUM |
| Generic Name | ASSAY, PORPHYRIN, SPECTROPHOTOMETRY, LITHIUM |
| Product Code | NDW |
| Date Received | 2011-05-13 |
| Model Number | NA |
| Catalog Number | 04679598190 |
| Lot Number | 61733301 |
| ID Number | NA |
| 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 | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-13 |