MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW G6PD TEST

Catalog Number	780000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Testing was unable to be performed at abbott diagnostics (b)(4), inc.On retained kit lot 114109 due to ongoing construction on site that prevents access to the specialized blood testing lab.A follow-up report with investigation results will be provided to the fda when completed.The manufacturing batch records and quality control release testing for kit part number 114109 were reviewed.This lot met the required release specifications.The current overall incident rate for false positive/negative patient results (including confirmed, unconfirmed, and conflicting) for this specific lot based on the total distributed devices is (b)(4).Based on the evidence available, it indicates that the lot performing within label claims overall.
Event or Problem Description
A customer reported a false normal result on a known deficient patient with the binaxnow g6pd test.The customer reported previous testing ((b)(6) 2020) was reported as deficient with the binaxnow g6pd test, confirmed deficient by spectrophotometry by the (b)(6) clinic.The patient was reported to have a hematocrit of 31.9% and white blood cell count of 3,600 at the time of the (b)(6) 2020 testing.Testing performed on (b)(6) 2020 (edta whole blood collected (b)(6) 2020) generated normal results with the binaxnow g6pd test.Repeat testing with the same sample, on the same kit lot, performed by a different operator also generated normal results on the binaxnow g6pd test.Confirmation testing by spectrophotometry by the (b)(6) clinic was deficient.The patient was reported to have a hematocrit of 26.5% and white blood cell count of 22,900.The customer stated the patient has cancer (not otherwise specified) and sickle cell trait, and had been administered wbc growth stimulator a few days prior to the (b)(6) 2020 testing.Attempts to gain further information were not successful.A diagnosis of g6pd deficiency is made in conjunction with other clinical tests and information and not solely on the outcome of the binaxnow g6pd test result.However, if primaquine anti-malarial drugs, sulfa drugs, or ascorbic acid are prescribed based on the binaxnow g6pd result, clinical complications such as acute hemolytic anemia could develop.This condition can be serious and life-threatening, therefore, this is a reportable event.
Additional Manufacturer Narrative
Additional information: retain testing was performed at abbott diagnostics scarborough, inc.With three replicates of presumed normal whole blood and three replicates of deficient control 20u/dl for both heparin and edta sample types.All testing performed as expected with no observations of false negative results.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however the false negative result may be due to the patient sample matrix.Review of complaints against the kit lot for the reported issue indicates product performance is within the claims made in the package insert and have not exceeded the upper control limit for further action.

• Brand Name: BINAXNOW G6PD TEST
• Common Device Name: BINAXNOW G6PD
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough, me
• MDR Report Key: 10228701
• Report Number: 1221359-2020-00125
• Device Sequence Number: 16929834
• Product Code: JBF
• UDI-Device Identifier: 10811877010705
• UDI-Public: 011081187701070510114109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 780000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1