MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-11-26 for ABBOTT TESTPACK RSV 2027-16 manufactured by Abbott Laboratories.
[101141]
On 10/30/97 a negative result for the testpack rsv assay was reported for a pt sample. The same pt sample later tested positive with an eia assay. A nasal washing sample was collected with a saline transport medium. The testpack protocol was followed, however the saline transport media was not used as a negative control. According to the account, the sample was stored for a few hrs 2-8c until tested and run one time with the testpack. No further pt info available. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[7766603]
The purpose of the investigation was to investigate the complaint for discrepant results of negative testpack rsv vs positive kallestad rsv. Using the returned kit material, two replicates of panel 0 (phosphate buffered saline) and two replicates of panel 1 (veal infusion broth), each known negatives, and two replicates of panel 2 (low antigen level rsv panel member) and one replicate of the returned testpack rsv positive control, were tested. In summary, returned material performed approx and met all performance criteria. Known negative samples yielded negative results which were clear and easy to interpret. Known positives read at the appropriate levels with bar intensities acceptable per reference photos (series 002). These masterlots performed according to package insert (83-4292/r2) claims. A false positive result on the kallestad kit cannot be ruled out. The kallestad rsv is not a confirmatory assay for abbott testpack rsv. Discrepant results may be due to sample handling, confirmatory methodology, assay technique and/or any assay's inherent limitations. The complaint is not confirmed. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1451914-1997-00034 |
| MDR Report Key | 135238 |
| Report Source | 05,06 |
| Date Received | 1997-11-26 |
| Date of Report | 1997-11-25 |
| Date of Event | 1997-10-30 |
| Date Mfgr Received | 1997-11-03 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1997-12-03 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT TESTPACK RSV |
| Generic Name | EIA FOR THE RAPID DETECTION OF RSV |
| Product Code | GQG |
| Date Received | 1997-11-26 |
| Returned To Mfg | 1997-11-21 |
| Model Number | NA |
| Catalog Number | 2027-16 |
| Lot Number | 34183M200 |
| ID Number | NA |
| Device Expiration Date | 1998-06-14 |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 132130 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION U.S. 41 & 22ND ST 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 | 1997-11-26 |