MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-06-16 for ABBOTT TESTPACK RSV 2027-16 manufactured by Abbott Laboratories.
[68141]
On 4/23/97, the account reported a negative result for the testpack rsv assay on a pt sample. According to the account, the infant had ingested 2 oz. Of similac to prior to obtaining the naspharyngeal wash specimen. The pt was discharged from the hospital on 4/25/97 and admitted to another hospital on 4/27/97. A new specimen, obtained at the other hospital, tested positive with rsv testpack kit, lot 26838m200. The pt was treated for rsv on 4/28/97 and discharged from the hospital. No report of injury. A positive result was received when the sample was first tested. The sample was received in a saline transport media. Saline was used as a negative control and performed as expected. The kit is stored at 2-8c and allowed to warm for 1 hour before use. According to the account, the "+" indicator on the pt sample appeared to be green in color and the account was use to seeing the "+" indicator as purple, and interpretted the result as invalid. Repeat testing of the sample gave a negative result, which was reported.
Patient Sequence No: 1, Text Type: D, B5
[6353476]
On 4/24/97, the account reported a discrepant result for the testpack rsv assay. The pt was originally tested on 3/31/97 at this hospital with testpack rsv kit, lot 24269m100, expiration date 10/30/97, and a positive result was reported. At that time, the physician decided not to treat the pt based on clinical symptoms. The pt was readmitted on 4/27/97 when the negative results were received from a nasopharyngeal was collected that day. The physician felt the pt should still be positive, as he had not previously received treatment for rsv. The pt has been discharged from the hospital. No report of injury. A positive result was received when the sample was first tested. The sample was received in a saline transport media. Saline, used as a negative control, performed as expected. According to the account, the "+" indicator on the pt sample appeared to be green in color instead of purple, which the account was use to seeing, and interpretted the result as invalid. Repeat testing of the sample gave a negative result, which was reported.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 1451914-1997-00028 |
| MDR Report Key | 113491 |
| Report Source | 05 |
| Date Received | 1997-06-16 |
| Date of Report | 1997-06-13 |
| Date of Event | 1997-04-24 |
| Date Mfgr Received | 1997-04-28 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1997-08-19 |
| 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 | 1997-06-16 |
| Model Number | NA |
| Catalog Number | 2027-16 |
| Lot Number | 24375M400 |
| ID Number | NA |
| Device Expiration Date | 1997-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 111414 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 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 | 1997-06-16 |
| 2 | 0 | 1. Other | 1997-06-16 |