MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-25 for CHEMSTRIP? 10 UA 11895354160 manufactured by Roche Diagnostics.
[2841069]
The initial result was "negative" for leukocytes on the chemstrip 10 ua. The result from the iris lab instrument came up as 1+ which is 250-500 leukocytes per microliter. The patient has been discharged from the hospital. The caller did not have any specific patient treatment information. No actions were reported taken based on either test. A request was made for the return of the meter and strips.
Patient Sequence No: 1, Text Type: D, B5
[10073024]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-03823 |
| MDR Report Key | 2669034 |
| Report Source | 06 |
| Date Received | 2012-07-25 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-17 |
| Device Manufacturer Date | 2011-10-13 |
| Date Added to Maude | 2012-07-25 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | LJX |
| Date Received | 2012-07-25 |
| Model Number | NA |
| Catalog Number | 11895354160 |
| Lot Number | 21155101 |
| ID Number | NA |
| Device Expiration Date | 2013-04-30 |
| 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 | 2012-07-25 |