MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-08-17 for ALBUSTIX manufactured by Kimball Electronics Poland Sp.z.o.o.
[18254528]
Customer reported discordant albustix result on urine strip.
Patient Sequence No: 1, Text Type: D, B5
[18419307]
Initial samples tested were a result of pt urinating directly on urine test strip. Labcorp result was obtained on a sample from the pt sample in a dixie cup. Pt was treated as a result of the elevated result. Customer was advised to send the urinalysis strips back to the manufacturer for testing. Returned product tested and complaint was not confirmed. Manufacturer believes user error related to complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00034 |
| MDR Report Key | 2710135 |
| Report Source | 07 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-16 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-07-16 |
| Date Added to Maude | 2012-08-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | KIMBALL ELECTRONICS POLAND SP.Z.O.O |
| Manufacturer Street | UL. POZNANSKA 1/C |
| Manufacturer City | TARNOWO PODGORNE 62080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALBUSTIX |
| Generic Name | ALBUSTIX |
| Product Code | CDM |
| Date Received | 2012-08-17 |
| Model Number | ALBUSTIX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBALL ELECTRONICS POLAND SP.Z.O.O |
| Manufacturer Address | UL. POZNANSKA 1/C TARNOWO PODGORNE 62080 PL 62080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |