MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-17 for SIEMENS CLINITEST HCG manufactured by Siemens.
[2249841]
The laboratory received complaints that the emergency room was getting numerous false positive and borderline pregnancy results on the clinitek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022695 |
| MDR Report Key | 2303291 |
| Date Received | 2011-10-17 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-10-10 |
| Date Added to Maude | 2011-10-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS CLINITEST HCG |
| Generic Name | HCG |
| Product Code | LCX |
| Date Received | 2011-10-17 |
| Lot Number | 031332 |
| Device Expiration Date | 2013-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-17 |