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

Catalog Number	780000
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The user reported multiple discrepancy results were found in several cases when performing the binaxnow g6pd kit.The customer reported there was about 7-8 cases, the first result showed g6bp defficient while the second repeat testing showed normal.The customer reported that they also confirmed results with a paralled run with quantitative g6pd test using a new box kit and turn out all the cases were found to be normal.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the reported.The customer reported the specimen type was edta whole blood the in lab which included 24 test and 15 failed.The samples were newly collected, and perform on same day.If suspected deficient, the sample would send out to perform quantitative test.The test devices were not exposed to direct sunlight or perform the test near a sunny window or fluorescent light for longer than 5 minutes prior to testing.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the previous report and provide the investigation conclusion.The manufacturing records and quality control release testing was reviewed for kit part number 780-000 / lot 120558 and device part number 780-430 / lot 119291.Quality control release testing met specifications and there were no conflicting results observed.The current overall incident rate for false patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).Based on the evidence available, it indicates that this device lot is performing within label claims.No further action is required.The retain kit was tested 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 conflicting results.The customer provided photographs for review: the investigator reviewed the customer's image of a repeated test with a new box of g6pd kit, both were normal results.In the photo two device cards are present.It was observed that the top card was labeled as 328r with temperature at 23.1c.This device has a dark strip on the top which represents a normal result.Its observed that the bottom card is labeled as 328l with temperature at 23.1c.This device has a dark strip on the top which represents a normal result.A second set of images provided from the customer showed a discrepancy with normal and deficient result.In this photo two device cards are present as well.It was observed that the device on top was labeled as 0328 (1) - this device has a dark strip on top which represents a normal result.The device on bottom is labeled as 0328 (2) - without the physical device in hand was difficult to see in just the photo, but at first glance it appeared to be a deficient result (no color change).Both devices do not have the temperature recorded on the front of the device, so it is unknown if they were run outside of the temperature listed.In conclusion, the manufacturing batch record review revealed that the product met acceptance criteria for release.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.

• Brand Name: BINAXNOW G6PD KIT
• Common Device Name: BINAXNOW G6PD KIT
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12701784
• Report Number: 1221359-2021-03312
• Device Sequence Number: 4613543
• Product Code: JBF
• UDI-Device Identifier: 10811877010705
• UDI-Public: 011081187701070510120558
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022

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?: No
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 780000
• Device Lot Number: 120558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 09/20/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 02/19/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown