MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-27 for COMBUR 10 TEST 04510062171 manufactured by Roche Diagnostics.
[6033600]
The customer complained of false negative erythrocytes (ery) results for an unknown number of patients when tested with "study" combur-10 urine test strips. The customer is comparing the combur-10 urine strips to siemens multistix which are tested on the siemens clinitek 50 instrument. The actual results have not been provided. This information has been requested. The date of event is not known. It is not known if the results are being used for diagnostic purposes. This information has been requested. It is not known if erroneous results were reported outside of the laboratory. It is not known if an adverse event occurred. No adverse event was reported. While the combur-10 urine strips are not sold in the us, the roche urine chemstrip is similar. Retention samples of the same lot that the customer used were tested. The reaction colors were acceptable and did not show any abnormalities. No false negative results were observed.
Patient Sequence No: 1, Text Type: D, B5
[14241418]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25826334]
All test strip specifications have been met for the retention samples tested. The customer has not made any further complaints about the strip lot used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03866 |
| MDR Report Key | 4943173 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-27 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-02 |
| Date Added to Maude | 2015-07-27 |
| 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 | 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 | COMBUR 10 TEST |
| Generic Name | BLOOD, OCCULT, COLORIMETRIC, IN URINE |
| Product Code | JIO |
| Date Received | 2015-07-27 |
| Model Number | NA |
| Catalog Number | 04510062171 |
| Lot Number | 22933001 |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-27 |