MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-01 for ALERE? I INFLUENZA A&B 425-024 manufactured by Alere Scarborough, Inc..
[98781825]
Qc had been run on instrument on 21 nov 2017. Storage of components appears correct. Person who ran test was identified and had been appropriately re-trained as it was confirmed that the wrong swab was utilized for sample collection. The manufacturing and quality control release testing was reviewed for alere i influenza a&b 24t m091620 and it met release specifications. No similar complaints for false negative results have been observed for this kit lot. 34536 total devices have been distributed; thus a (b)(4)% complaint rate for false negative results including this case. Alere (b)(4) also tested devices with flu a positive controls, flu b positive controls, presumed negative nasal swabs , negative transport media, and 0. 9% saline. All testing performed as expected; all positive samples produced positive results and all negative samples produced negative results. The log files from alere instrument (b)(4) were reviewed and a test result was available (b)(6) 2017 at 16:13 with a valid flu a negative / flu b negative result. Additionally, there is a test result available from (b)(6) 2017 at 16:48 with a valid flu a negative / flu b negative result. It is unknown (customer is unable to confirm) which test is related to the patient in this case. Per the limitation section of the package insert included in the kit for lot m091620: - "false negative results may occur if a specimen is improperly collected, transported or handled. False negative results may occur if inadequate levels of viruses are present in the specimen. " - "negative results do not preclude infection with influenza virus and should not be the sole basis of a patient treatment decision. " additionally, the following clinical performance data related to false negative results is included in the package insert: sensitivity vs. Viral culture (direct nasal swab): flu a: 92/94 97. 9% (95%ci: 92. 6%-99. 4%). Flu b: 74/80 92. 5% (95%ci: 84. 6%-96. 5%). It appears the alere i influenza a&b test was performing within the claims of the device contained in the package insert.
Patient Sequence No: 1, Text Type: N, H10
[98781826]
On (b)(6) 2018, a customer in the (b)(6) reported to alere (b)(4) that a (b)(6) year old female patient presented on (b)(6) 2017 to the hospital (b)(4) with typical cold symptoms - shortness of breath, sore throat and anxiety - and was admitted at 10:30 with subsequent transfer to resus at 11:30. The alere i influenza a&b test was run at 16:13 using a direct nasal swab with a negative result. Customer confirmed the wrong swab was used to run the alere i influenza a&b test and suspects there was not a lot of sample. The patient's condition worsened and was transferred to itu at 18:30. In itu, additional throat and nose samples were collected, pooled and sent off the (b)(6) laboratory for further testing. The patient expired on (b)(6) 2017 at 22:05 prior to availability of influenza positive rt-pcr confirmatory lab results on (b)(6) 2017. Cause of death reported by the customer was neutropenic sepsis and thinks death was a direct consequence of having influenza; however, customer does not have post mortem results available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221359-2018-00003 |
| MDR Report Key | 7234064 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-01 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2017-10-03 |
| Date Added to Maude | 2018-02-01 |
| 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 | 3 |
| Manufacturer Contact | MS. DANIELLE BRIGGEMAN |
| Manufacturer Street | 10 SOUTHGATE ROAD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE? I INFLUENZA A&B |
| Generic Name | ALERE? I FLU, ALERE? I, ALERE? INFLUENZA A & B |
| Product Code | OCC |
| Date Received | 2018-02-01 |
| Catalog Number | 425-024 |
| Lot Number | M091620 |
| Device Expiration Date | 2018-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SCARBOROUGH, INC. |
| Manufacturer Address | 10 SOUTHGATE ROAD SCARBOROUGH ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-01 |