MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-11-05 for ABBOTT TESTPAK RSV 2027-16 manufactured by Abbott Laboratories, Inc..
[162424]
On 09/21/1999 the account reported positive testpack rsv results and the patient was treated with riboviran and respogam. Polymerase chain reaction, culture, direct fluorescent antibody 2x (by two different methods), and directogen were all negative. Further information from the account stated that a bone marrow transplant was postponed due to the false positive testpack rsv results. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-1999-00018 |
| MDR Report Key | 249120 |
| Report Source | 06 |
| Date Received | 1999-11-05 |
| Date of Report | 1999-11-03 |
| Date of Event | 1999-09-21 |
| Date Mfgr Received | 1999-10-06 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 1999-11-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN, D-09V1,AP34-2 |
| Manufacturer Street | 200 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479372688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT TESTPAK RSV |
| Generic Name | EIA FOR THE RAPID DETECTION OF RSV |
| Product Code | GQG |
| Date Received | 1999-11-05 |
| Model Number | NA |
| Catalog Number | 2027-16 |
| Lot Number | 57128M200 |
| ID Number | NA |
| Device Expiration Date | 2000-05-01 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 241352 |
| Manufacturer | ABBOTT LABORATORIES, INC. |
| Manufacturer Address | U.S. 41/22ND AVE. NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | TESTPACK RSV |
| Baseline Generic Name | EIA FOR THE RAPID DETECTION OF RSV |
| Baseline Model No | NA |
| Baseline Catalog No | 2027-16 |
| Baseline ID | NA |
| Baseline Device Family | TESTPACK RSV |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K874127 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-05 |