MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-11-15 for TESTPACK PLUS HCG-COMBO 7B34-16 manufactured by Abbott Laboratories.
[345290]
The account generated negative testpack plus hcg combo results using urine speciments on two patients from the emergency room who tested hcg quantitative positive. This report is for patient 1 of 2 total patients. Patient 1 tested testpack plus hcg combo negative (urine specimen), testpack plus hcg combo weakly positive (serum specimen), icon ii hcg combo positive and hcg quantitative method = 66 (no units of measurement given). It is unknown if the urine specimen for patient 1 was random or first a morning specimen. No additional patient or testing information is available. The negative testpack plus hcg combo result was reported outside of the laboratory. A corrected report was submitted to the physician. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-2004-00004 |
| MDR Report Key | 580039 |
| Report Source | 06 |
| Date Received | 2004-11-15 |
| Date of Report | 2004-11-10 |
| Date Mfgr Received | 2004-10-13 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2005-03-11 |
| 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 SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| 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-COMBO |
| Generic Name | RAPID PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2004-11-15 |
| Model Number | NA |
| Catalog Number | 7B34-16 |
| Lot Number | 16006M200 |
| ID Number | NA |
| Device Expiration Date | 2005-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 569887 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION U.S. 41 & 22ND ST NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | TESTPACK PLUS HCG COMBO WITH OBC |
| Baseline Generic Name | RAPID PREGNANCY TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 7B34-16 |
| Baseline ID | * |
| Baseline Device Family | TESTPACK PLUS HCG-COMBO |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 2 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K965116 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-15 |