MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-03 for CHEMSTRIP 10 UA 11895354160 manufactured by Roche Diagnostics.
[1852373]
The user received a questionable erythrocyte result for one patient urine sample from the urisys 1100 urine analyzer (b)(4). The initial result was negative. The result from the laboratory on a "cua" with the same lot number of chemstrips was "++" and a visual reading of the chemstrip was also positive. No adverse events were alleged regarding the issue. The user stated she thought the issue may have been caused by the tray on the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[9023203]
Additional information was received from the user stating the assay involved was leukocytes, not erythrocytes as previously reported on the initial medwatch. The repeat result on a "cua" was "++" which the user stated equals 500 leu/ul. The initial result was reported to the physician who ordered testing in the laboratory to confirm the negative result.
Patient Sequence No: 1, Text Type: N, H10
[9043560]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9104640]
.
Patient Sequence No: 1, Text Type: N, H10
[9280367]
The results of the investigation with the user's device showed that the values were slightly lower in comparison to a reference method. However, the difference was not potentially critical and was not a risk for the user or the patient. The suspect tray was not available for investigation, therefore, no specific root cause could be determined. No adverse events were alleged regarding the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02349 |
| MDR Report Key | 2074923 |
| Report Source | 05,06 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-04-08 |
| Date Mfgr Received | 2011-04-08 |
| Date Added to Maude | 2011-05-03 |
| 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 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEMSTRIP 10 UA |
| Generic Name | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) |
| Product Code | JIO |
| Date Received | 2011-05-03 |
| Model Number | NA |
| Catalog Number | 11895354160 |
| Lot Number | 20031104 |
| ID Number | NA |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-03 |