MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2015-04-29 for URISTIX 4 10627148 manufactured by Siemens Healthcare Diagnostics.
[21942643]
Customer stated that consumer reported 3 discordant protein results on the urinalysis strips. Consumer read all 3 results visually. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[22222751]
Customer was instructed that the strips are meant to be used for screening and not confirmatory. Customer was provided with new strips and per customer the new strips are working according to her expectations. Customer has been requested to send affected strips back for investigation. The cause for the discordant protein results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[33622389]
Siemens technical operation team investigated customer's returned bottle of reagent strips. Investigation: visual evaluation of returned reagent strips showed no obvious damage/degradation. Performance test of returned reagent strips completed using (a) negative urine, (b) positive control solution, & (c) urine spiked to 30mg/dl pro. Testing was done by visual method under typical laboratory lighting using a single qualified reader. N=5 replicates per test solution. Conclusion: all tested reagent strips were observed to have uniform color development yellow for strips tested with negative urine. Medium green for strips tested with positive control solution. Medium green for strips tested with positive urine. Customer's returned bottle of reagent strips evaluated and alleged failure could not be duplicated. The cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00053 |
| MDR Report Key | 4737729 |
| Report Source | 04,05,07 |
| Date Received | 2015-04-29 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2015-06-02 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBALL ELECRONICS |
| Manufacturer Street | UL. POZENANSKA 1/C POLAND SP.Z O.O |
| Manufacturer City | TARNOWO PODGORNE, 62080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62080 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URISTIX 4 |
| Generic Name | URISTIX 4 |
| Product Code | JIR |
| Date Received | 2015-04-29 |
| Catalog Number | 10627148 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-29 |