MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2006-12-12 for BINAXNOW INFLUENZA A & B 416-000 manufactured by Binax, Inc (d.b.a. Inverness Medical Professional Diagnostics).
[579528]
Binax, inc. D/b/a inverness medical professional diagnostics (impd), scarborough - technical services received a phone call from the hospital, in 2006 who reported 10 false positive flu a results using the nowbinax influenza a&b kit since the beginning of october 2006. Results were negative by dfa. The customer mentioned that a young child that also had a positive result and negative pcr had died. Upon further inquiry, the hospital personnel indicated that the young child was a girl admitted in 2006 and died the next day. Test results for this patient were reported to binax. Inc d/b/a/impd.
Patient Sequence No: 1, Text Type: D, B5
[7914483]
Under "specimen collection and handling" section of the product insert, the manufacturer recommends use of "fresh nasopharyngeal and nasal wash/aspirates" for best test performance and under the "limitations" sections states that "use of visibly bloody samples is not recommended". This patient's sample (bloody and potentially a tracheal aspirate) represent an off-label use. Even though the patient died, this adverse event was not considered to be associated with the use of the binaxnow flu a&b kit since the hospital reported this event to the manufacturer approximately 30 days after the event occurred. Neither the patient specimens nor the kit used were available to conduct any further testing of these materials at binax inc, d/b/a impd. A complete review of the device history records for lot 024252 was conducted. There were no anomalies/discrepancies to the quality system. Testing was performed using the retain samples binaxnow influenza a&b kit lot 024252. All test results met release specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2006-00001 |
| MDR Report Key | 793684 |
| Report Source | 04,05,06 |
| Date Received | 2006-12-12 |
| Date of Event | 2006-10-16 |
| Date Mfgr Received | 2006-11-14 |
| Date Added to Maude | 2006-12-14 |
| 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 Street | 10 SOUTHGATE RD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BINAXNOW INFLUENZA A & B |
| Generic Name | FLU A/B |
| Product Code | GNX |
| Date Received | 2006-12-12 |
| Model Number | NA |
| Catalog Number | 416-000 |
| Lot Number | 024252 |
| ID Number | NA |
| Device Expiration Date | 2007-07-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 781301 |
| Manufacturer | BINAX, INC (D.B.A. INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS) |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH ME 04032 US |
| Baseline Brand Name | BINAXNOW INFLUENZA A & B |
| Baseline Generic Name | FLU A/B |
| Baseline Model No | NA |
| Baseline Catalog No | 416-000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-12 |