MAUDE Adverse Event Report: ALERE SCARBOROUGH, INC. ALERE I INFLUENZA A&B; ALERE¿ I FLU, ALERE¿ I, ALERE¿ INFLUENZA A & B

Catalog Number	425-024
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Death (1802); Misdiagnosis (2159)
Date of Event	12/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ALERE I INFLUENZA A&B
• Common Device Name: ALERE¿ I FLU, ALERE¿ I, ALERE¿ INFLUENZA A & B
• Manufacturer (Section D): ALERE SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 7234064
• Report Number: 1221359-2018-00003
• Device Sequence Number: 19289207
• Product Code: OCC
• UDI-Device Identifier: 10811877010804
• UDI-Public: 011081187701080410M091620
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2018
• Device Catalogue Number: 425-024
• Device Lot Number: M091620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 33 YR