MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-03-25 for ABBOTT TESTPACK RSV 2027-16 manufactured by Abbott Laboratories.
[7771159]
Investigation results: no customer return received. File material performed appropriately meeting all performance criteria. Known negative samples yielded negative results. Negatives were clear, clean, and easy to interpret. Known positives were picked up at appropriate levels with bar intensities acceptable. In response to the customer stating that a faintly positive result is interpreted by the majority of techs as negative, any color on the vertical bar is a positive result. Since the customer did not return the kit, patient sample, or a sample of their transport media for evaluation, further analysis cannot be performed. The complaint was not confirmed. Evaluation complete-final report.
Patient Sequence No: 1, Text Type: N, H10
[15483743]
The account stated they obtained discrepant results when using the rsv kit. The account stated that when a rapid assay is run, the negative assays are sent to a reference lab for fa. The method of fa is unkown. The account stated they had a incident which gave a negative result on the kit and positive on fa, but when the sample was repeated in the lab it was positive. The reporter attributed this to opertor error as the kit was allowed to sit out at room temperature for 5-10 minutes before use. Label states kit reagents and reaction discs must be at room temperature prior to use (minimum 30 minutes). Additional info indicates they had another sample which was negative on the kit and positive with fa. One pt was a baby admitted with upper respiratory problems. The negative result from rsv kit impacted pt since treatment was delayed for about 24 hours until fa result received and pt was not treated or isolated. No additional info on pts available due to confidentiality issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-1997-00018 |
| MDR Report Key | 81016 |
| Report Source | 05 |
| Date Received | 1997-03-25 |
| Date of Report | 1997-03-25 |
| Date of Event | 1997-01-20 |
| Date Mfgr Received | 1997-02-24 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1997-04-04 |
| 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 | 3 |
| 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 | 1997-03-25 |
| Model Number | NA |
| Catalog Number | 2027-16 |
| Lot Number | 24251M100 |
| ID Number | NA |
| Device Expiration Date | 1997-10-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 80461 |
| 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 | 1. Other | 1997-03-25 |