MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PRECISET DAT PLUS I; DRUG MIXTURE CALIBRATORS

Catalog Number 03304671190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During correlation testing of 10 randomly pulled patient samples for benz benzodiazepines plus (benz) on a cobas 6000 c (501) module, the customer initially questioned results for 1 patient sample.The customer complained that 1 patient sample had tested positive for benz at the customer site.The customer is running benz as a qualitative test with a cutoff of 300 ng/ml.When the sample was repeated at sister sites on 2 other c501 modules, the results were negative.This sample was sent out for gas chromatography/mass spectrometry (gc/ms) confirmatory testing where the result was negative.The negative results are believed to be correct.The customer also mentioned 5 additional patient samples where the benz results were positive at the customer site and negative when repeated on a cobas 8000 system.These 5 samples were also sent out for gc/ms confirmatory testing.Of these 5 samples, 1 patient sample had an interference preventing accurate identification, 2 patient samples were positive and 2 patient samples were negative.There was no allegation that an adverse event occurred.The c501 module serial number was (b)(4) the benz reagent lot number was 20897601 with an expiration date of 10/31/2018.The customer believes there was a calibrator that was put in use in april 2017 (lot 179984) that was "defective." the customer calibrated with a new calibrator lot (205878) loaded on (b)(6) 2017 and all of the samples that had previously tested positive for benz were now negative.The customer ran the negative roche dat controls prior to calibrating on (b)(6) 2017 and those results were positive.After calibrating, the results were negative.The customer also ran the old calibrator lot and the new calibrator lot as patients and received absorbance values of 5 with the new lot and (-) 149 with the old lot.The customer is now using the c501 module and reporting benz results again.The field service engineer (fse) visited the customer site.The customer ran roche quality controls (qc) and both were positive.The customer then ran a different shipment of the calibrator and qc again and received the correct results.The fse inspected the system and identified a misaligned and dirty sample probe and misaligned reagent probes.The fse also noted that the ultra sonic mixer splash guard was bent and scratching the top of the reaction cells, the ise sipper tube was installed incorrectly and the gear pump gauge had failed.The gear pump gauge was replaced and adjusted.The customer ran qc and all results were within specification.

Manufacturer Narrative

Upon a follow up call with the customer, none of the initial results for the 5 additional patient samples tested were changed based on the gc/ms results.The field application specialist (fas) discussed proper cassette handling/mixing with the customer and assisted with new calibration and quality control testing.The issue was resolved by using calibrator material from a different shipment.The investigation determined that the root cause of the erroneous results was the calibrator.

Manufacturer Narrative

Product problem was corrected.

• Brand Name: PRECISET DAT PLUS I
• Type of Device: DRUG MIXTURE CALIBRATORS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6614673
• MDR Text Key: 76834578
• Report Number: 1823260-2017-01161
• Device Sequence Number: 1
• Product Code: DKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 03304671190
• Device Lot Number: 17998401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• 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: N
• Patient Sequence Number: 1