MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-03-17 for TESTPACK PLUS HCG-URINE 3C07-16 manufactured by Abbott Laboratories.
[21711180]
The account stated a pt sample generated a negative testpack plus hcg urine result when read at 5 minutes but after 10 minutes, the result changed to positive. Both the control bar and end of assay window contained color at 5 minutes, indicating the assay was valid. It is unk whether the urine sample was a first morning or random sample. The pt tested positive on quantitative hcg. There was no impact to pt management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-2006-00001 |
| MDR Report Key | 689611 |
| Report Source | 01,06 |
| Date Received | 2006-03-17 |
| Date of Report | 2005-12-03 |
| Date of Event | 2005-12-03 |
| Date Mfgr Received | 2005-12-03 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-03-21 |
| 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 | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TESTPACK PLUS HCG-URINE |
| Generic Name | RAPID PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2006-03-17 |
| Model Number | NA |
| Catalog Number | 3C07-16 |
| Lot Number | 19473M200 |
| ID Number | NA |
| Device Expiration Date | 2006-12-20 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 678788 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION U.S. 41 & 22ND ST NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | TESTPACK +PLUS HCG URINE |
| Baseline Generic Name | QUALITATIVE URINE PREGNANCY TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 3C07-16 |
| Baseline ID | NA |
| Baseline Device Family | TESTPACK +2 URINE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 13 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954029 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-17 |