MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-24 for CLINITEK STATUS 10332185 manufactured by Siemens Healthcare Diagnostics Inc.
[3846050]
Customer reported positive results for urobilinogen, nitrites and leukocytes on the instrument whereas microscopic results were negative for all three analytes. Customer indicated that leukocyte pad on the 10sg strips had turned to a pink color. Customer purchases the strips from a distributor. Customer also indicated that he has previously seen aberrant leukocyte and nitrite results on other patient samples but did not indicate how many. There was no injury reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11250363]
Customer is being provided with 2 new bottles of multistix strips. The cause for the discordant urobilinogen, leukocytes and nitrites results is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00196 |
| MDR Report Key | 3445242 |
| Report Source | 07 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-10-01 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2013-10-01 |
| Date Added to Maude | 2013-12-03 |
| 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 | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG, LTD |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS |
| Generic Name | CT STATUS |
| Product Code | JIR |
| Date Received | 2013-10-24 |
| Catalog Number | 10332185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-24 |