MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW G6PD KIT; GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING

Catalog Number	780-000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event provided in section b3 is an approximation, was not provided by consumer.D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 181228 with internal positive quality control samples and negative quality control samples.All test results were valid and performed as expected.No false negative(normal) results were observed, and the customers complaint was not replicated.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 780-000 / lot 195040, test base part number 780-430 / lot 194666.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 195040 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue h3 other text single-use, device discarded.
Event or Problem Description
The customer reported four (4) false negative results with the binaxnow g6pd kit performed on unknown dates.This mfr.Report addresses test two (2) of four (4).Confirmation elisa testing was performed on an unknown date, which generated a positive result.Repeat testing was performed thrice on the same sample and once on a new sample at an interval of 2 weeks, which each generated a negative result.The customer reported there was an impact in the patient's treatment; a drug contraindicated for g6pd deficiency was prescribed and taken.The name of the drug was not provided.The customer confirmed there was death or no serious injury based on the test results.Although requested, no additional patient information, including outcome, was provided.

• Brand Name: BINAXNOW G6PD KIT
• Common Device Name: GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 18024439
• Report Number: 1221359-2023-01593
• Device Sequence Number: 7556843
• Product Code: JBF
• UDI-Device Identifier: 10811877010705
• UDI-Public: 10811877010705
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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: 03/08/2024
• Device Catalogue Number: 780-000
• Device Lot Number: 195040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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