MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-04 for CHEMSTRIP? 10 UA 11895354160 manufactured by Roche Diagnostics.
[2692024]
The user received questionable urinalysis results for one patient sample from the urisys 1100 analyzer serial number (b)(4). Of the data provided, the result for leukocytes was discrepant. The initial result was "negative" for leukocytes. The result from the criterion ii meter for leukocytes is 100 wbc/ul. The caller did a microscopic confirmatory test which showed 0-2 wbc/hpf for leukocytes. No information was provided to determine if the erroneous result was reported outside the laboratory. The caller does not have any specific patient information. No actions were reported taken based on either test.
Patient Sequence No: 1, Text Type: D, B5
[9834406]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[16326729]
The strips were not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-02408 |
| MDR Report Key | 2560219 |
| Report Source | 06 |
| Date Received | 2012-05-04 |
| Date of Report | 2012-05-24 |
| Date of Event | 2012-04-02 |
| Date Mfgr Received | 2012-04-09 |
| Date Added to Maude | 2012-05-04 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | 2012-05-04 |
| Model Number | NA |
| Catalog Number | 11895354160 |
| Lot Number | 20835301 |
| ID Number | NA |
| Device Expiration Date | 2012-11-30 |
| 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 | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-04 |