MAUDE Adverse Event Report: BIOKIT S.A. BIO-FLASH; SYSTEM MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Catalog Number	3710-0344
Medical Device Problem Codes	False Negative Result (1225); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Kidney injury (4882)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The quanta flash® gbm is a chemiluminescent immunoassay (cia) for the semi-quantitative detection of igg anti-glomerular basement membrane (gbm) autoantibodies in human serum on the bio-flash® instrument.Quanta flash® gbm is an aid in the diagnosis of goodpasture's syndrome in conjunction with clinical findings and other laboratory tests.Complaint (b)(4) reported that a patient with acute kidney injury presented with a negative quanta flash gbm reagent (lot number 244154) result on (b)(6) 2024.On (b)(6) 2024 the sample was retested using the phadia mpo and pr-3 assays, which tested low positive for mpo and negative for pr-3.A biopsy was ordered (date unknown) based upon the phadia low positive mpo test result.The biopsy was positive for igg anti-glomerular basement membrane (gbm) disease.Plex treatment (plasma exchange) was administered following the biopsy results.However, the customer reported that the delay in diagnosis led to irreversible destruction of organ and permanent need for dialysis.
Event or Problem Description
The quanta flash® gbm is a chemiluminescent immunoassay (cia) for the semi-quantitative detection of igg anti-glomerular basement membrane (gbm) autoantibodies in human serum on the bio-flash® instrument.Quanta flash gbm is an aid in the diagnosis of goodpasture's syndrome in conjunction with clinical findings and other laboratory tests.Complaint (b)(4) reported that a patient with acute kidney injury presented with a negative quanta flash gbm reagent (lot number 244154) result on (b)(6) 2024.On (b)(6) 2024 the sample was retested using the phadia mpo and pr-3 assays, which tested low positive for mpo and negative for pr-3.A biopsy was ordered (date unknown) based upon the phadia low positive mpo test result.The biopsy was positive for igg anti-glomerular basement membrane (gbm) disease.Plex treatment (plasma exchange) was administered following the biopsy results.However, the customer reported that the delay in diagnosis led to irreversible destruction of organ and permanent need for dialysis.
Additional Manufacturer Narrative
Based upon the information received and the investigation performed, the cause of the reported event is likely related to instrument performance.The instrument log review conclusion was that a combination of errors observed is suggestive that instrument performance at the time of the initial test results could have impacted sample results.An inova field service engineer (fse) was dispatched to the customer site.The fse performed multiple alignments, maintenance processes, and part replacements; instrument performance was verified and the customer was notified that the analyzer was ready for use.Due to multiple interventions performed, a specific part cannot be identified as the sole contributor of this event.A failure of one or more of the instrument components is the most likely cause of this event.No further issues have been noted following the servicing of the instrument.

• Brand Name: BIO-FLASH
• Common Device Name: SYSTEM MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): BIOKIT S.A.; av. can montcau 7; lliçà d'amunt - barcelona, CA 08186 ; SP 08186
• Manufacturer (Section G): BIOKIT S.A.; av. can montcau 7; lliçà d'amunt - barcelona, CA 08186 ; SP 08186
• Manufacturer Contact: angels roma ; av. can montcau 7; lliçà d'amunt - barcelona, CA 08186 ; 8585869000
• MDR Report Key: 21031210
• Report Number: 2026994-2024-00001
• Device Sequence Number: 9155481
• Product Code: JPA
• UDI-Device Identifier: 08426950639725
• UDI-Public: 08426950639725
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 04/01/2025
• Device Catalogue Number: 3710-0344
• Device Lot Number: 244154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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; Disability
• Patient Sex: Unknown