PRECISET DAT PLUS I 03304671190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-06 for PRECISET DAT PLUS I 03304671190 manufactured by Roche Diagnostics.

Event Text Entries

[76834578] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[76834579] 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.
Patient Sequence No: 1, Text Type: D, B5


[115804908] 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.
Patient Sequence No: 1, Text Type: N, H10


[132596326] Product problem was corrected.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2017-01161
MDR Report Key6614673
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-06-06
Date of Report2018-09-20
Date of Event2017-05-12
Date Mfgr Received2017-05-17
Date Added to Maude2017-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePRECISET DAT PLUS I
Generic NameDRUG MIXTURE CALIBRATORS
Product CodeDKB
Date Received2017-06-06
Model NumberNA
Catalog Number03304671190
Lot Number17998401
ID NumberNA
Device Expiration Date2017-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-06

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