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.
[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
| Report Number | 1823260-2017-01161 |
| MDR Report Key | 6614673 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-06 |
| Date of Report | 2018-09-20 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISET DAT PLUS I |
| Generic Name | DRUG MIXTURE CALIBRATORS |
| Product Code | DKB |
| Date Received | 2017-06-06 |
| Model Number | NA |
| Catalog Number | 03304671190 |
| Lot Number | 17998401 |
| ID Number | NA |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-06 |