MAUDE Adverse Event Report: INFINITY BIOLOGIX DBA SAMPLED INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY

Catalog Number A147814

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

After investigation, the root cause was determined to be a lack of standard method - sop 5009-0072 mn coviod-19 data submission was published and the responsible staff were trained on the procedure.98 reports were amended and submitted to the client.

Event Description

On (b)(6) 2022, the technician noted that a plate was incorrectly loaded for 372 samples.Due to this discrepancy, the samples had to be re-run.Before the re-run was complete, the sample submissions team submitted the results for the original run.Of the 372 samples, 98 samples had incorrect results reported, with 87 of those (first 2 bullets) reports having an impact to a patient.44 reported as detected and should be "not-detected" 43 reported as not-detected and should be "detected" 10 reported a not-detected and should be "indeterminate" 1 reported as detected and should be "indeterminate".

• Brand Name: INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY
• Type of Device: TAQPATH SARS-COV-2 ASSAY
• Manufacturer (Section D): INFINITY BIOLOGIX DBA SAMPLED; 145 bevier rd; piscataway NJ 08854
• Manufacturer (Section G): INFINITY BIOLOGIX DBA SAMPLED; 145 bevier rd; piscataway NJ 08854
• Manufacturer Contact: gary price ; 145 bevier rd; piscataway, NJ 08854 ; 8484457137
• MDR Report Key: 15843323
• MDR Text Key: 307800476
• Report Number: 3020585577-2022-00264
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: A147814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1