MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-04 for PRODESSE PROFLU ASSAY 303110 manufactured by Hologic Incorporated.
[32693384]
The patient was a (b)(6) year-old male who tested negative by the proflu+ assay. One week after negative testing, the patient expired. The sample was re-tested by the (b)(6) public health and was positive for ia/h3. Another sample taken from the patient one week prior to the negative proflu+ assay, tested positive on the proflu+ assay though it is unclear if this sample was used in the patient's clinical evaluation. False negative values may be the result of improper collection, transport, or handling of specimens as well as procedural errors, amplification inhibitors in specimens, or inadequate numbers of organisms for amplification. Because an earlier specimen tested positive with the proflu+, it is apparent that the viral strain was detectable with the hologic assay and is unlikely the cause of a false positive test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00005 |
| MDR Report Key | 5267520 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-04 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-11-09 |
| Date Added to Maude | 2015-12-04 |
| 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 | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal | 92129 |
| Manufacturer Phone | 8584108167 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODESSE PROFLU ASSAY |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | OCC |
| Date Received | 2015-12-04 |
| Catalog Number | 303110 |
| Lot Number | 146310 |
| Device Expiration Date | 2016-06-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-12-04 |