MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) TAQPATH COVID-19 COMBO KIT

Catalog Number A47814

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Thermo fisher scientific reviewed and analyzed 237 software data log files provided by the customer and identified 79 false positive calls amongst the 15,815 patient samples ran between (b)(6) 2020 (0.5%).The root cause was determined to be insufficient mixing and centrifugation of the qpcr plates.In addition, in four of the data files, the amplification curves revealed suspected evaporation due to an incomplete plate seal.The following data files contained false positive results: (b)(6).The thermo fisher field application scientist assigned to this account re-trained the customer to vortex the plates according to the instructions in the ifu, including not using a plate shaker to perform the vortexing steps.The ifu states "vortex the plate at the highest setting speed for 10-30 seconds with medium pressure.Move the plate around to ensure equal contact on the vortex mixer platform." since amending their workflow, the customer has not reported additional problems since.

Event Description

Customer submitted a complaint on (b)(6) 2020 regarding discordant results across multiple runs of the same sample.The results from this sample were provided to the ordering physician.Customer retested the sample and corrected results were provided to the physician.Analysis of the customer's data by thermo fisher scientific's field application scientist (fas) revealed systematic issues with optical mixing (an irregular baseline at the beginning of cycling), due to insufficient vortexing of the qpcr plates.A review of the customer's workflow indicated that the customer was using a plate shaker instead of a vortex to mix the plates, which is a deviation from the instructions for use.The customer did not report any deaths or serious injuries to thermo fisher scientific.

• Brand Name: TAQPATH COVID-19 COMBO KIT
• Type of Device: TAQPATH COVID-19 COMBO KIT
• Manufacturer (Section D): LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC); 6055 sunol boulevard; pleasanton, ca
• Manufacturer (Section G): LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC); 6055 sunol boulevard; pleasanton, ca
• Manufacturer Contact: kelli tanzella ; 3175 staley rd; grand island, ny
• MDR Report Key: 10491647
• MDR Text Key: 252413896
• Report Number: 3009976420-2020-00016
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/03/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: A47814
• Device Lot Number: 2005122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1