MAUDE Adverse Event Report: ROCHE DIAGNOSTICS C.F.A.S. PROTEINS; CALIBRATOR, MULTI-ANALYTE MIXTURE

Catalog Number 11355279216

Device Problem High Test Results (2457)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).Expiration date was provided as november 2018.

Event Description

The customer stated that they received an erroneous result for one patient sample tested for aat2 tina-quant ¿1-antitrypsin ver.2 (aat) on a cobas 8000 c 702 module (c702).The customer complains about patient sample recovery with a new c.F.A.S.Proteins (cfas) calibrator lot number, 14434401.The customer ran a comparison of the old cfas calibrator lot (186510) to the new cfas lot using 40 patient samples.Patient samples were tested using the new calibrator lot on the c702 analyzer and the same samples were tested on a different analyzer using the old calibrator lot.The customer ran the samples on both analyzers within a short period of time.There was an 11.5% difference in patient values when comparing the results obtained with the different calibrators.The customer is concerned because there is a direct relation between the aat results of patient samples and treatment that their patients receive.Of the 40 patient samples, one had an erroneous result.It was asked, but it is not known if the erroneous result was reported outside of the laboratory.The sample resulted with an aat value of 1.23 g/l when tested on the c702 analyzer using the new calibrator lot.The sample resulted as 0.86 g/l when tested on the other analyzer using the old calibrator lot.No adverse events were alleged to have occurred with the patient.The aat reagent lot number was asked for, but not provided.The c702 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

Method comparisons of the two calibrator lots were performed with patient samples.All results were within specified limits.

Manufacturer Narrative

In 2016, a new aat reagent lot (lot 613722) had an elevated control recovery of about +8%.This was determined to be due to a change in the antibody quality in the reagent.Human samples were not affected and there was no violation of specifications for the reagent.New cfas calibrator lot 144344 was standardized using this new reagent lot number (lot 613722).As a result, the new cfas calibrator lot 144344 shifted +8%, in turn causing a -8% shift in patient results.The old cfas calibrator lot (lot 186510) was standardized using an older reagent lot number.During investigations, measurements were performed using one c702 analyzer, one reagent pack (lot 193958), three calibrators (lots 186510, 144344, and 199428), and 13 samples per calibration.Retention materials were used.Samples: 1 x erm-da470k-ifcc standard, 1 x cfas p lot 186510, 1 x cfas p lot 144344, 1 x cfas p lot 199428, 1 x pccc1 lot 186373, 1 x pccc2 lot 160386, 5 x human sera, 2 x human sera, manually diluted with nacl.Result: controls: pccc1 and pccc2 recovered within 1 sd range.Measurements calibrated with cfas p 144344 and cfas p 199428 are comparable to each other, while measurements calibrated with cfas p 186510 differs when compared to measurements performed with the other cfas lots.Measurements calibrated with cfas p 186510 show a difference of around 6-8% to the measurements calibrated with cfas p 144344 and 199428.Aat is traceable to erm-da470k-ifcc.Erm-da470k-ifcc recovery is with cfas p 144344 and 199428 quite low while with cfas p 186510 recovery is around 100%.Quality control recovery is within criteria of +/- 10%.Human sera comparison is > 10% difference.

• Brand Name: C.F.A.S. PROTEINS
• Type of Device: CALIBRATOR, MULTI-ANALYTE MIXTURE
• 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: 6797166
• MDR Text Key: 83305230
• Report Number: 1823260-2017-01706
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2017

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: 11355279216
• Device Lot Number: 14434401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 07/25/2017
• Supplement Dates FDA Received: 10/09/2017; 12/13/2017
• 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