MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT K+ FOR GEN.2; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number 10825441001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer received questionable ise indirect na, k, ci for gen.2 on a cobas 8000 cobas ise module, serial number (b)(4).The sample was processed by the modular preanalytic analyzer (mpa).After routine qc was out of the acceptable range, the customer repeated the qc which failed, performed calibration, and again ran qc which then passed.During this time period, 99 patient samples were tested for the ise assays and were reported outside the laboratory.All of these samples were repeated and 95 of the samples required corrected reports.Data was only provided for one patient sample as an example.The initial sodium result was 131 mmol/l and the repeat result was 143 mmol/l.The initial potassium result was 4.5 mmol/l and the repeat result was 5.0 mmol/l.There was no adverse event.The field service representative found the electrodes had failed.He inspected the system and replaced the electrodes he ran a precision check, calibration and qc with no further issues.Refer to the medwatch with patient identifier (b)(6) for the sodium assay.

Manufacturer Narrative

Further investigation determined the root cause was most probably an operator handling issue as the calibration prior to the patient sample testing was likely performed with concentrated standards due to evaporation.The provided calibration data showed differing values for standards 1-3 compared to previous calibrations.Instead of replacing the standards by fresh ones, the recalibration was most probably performed with the same vials.Since the qc associated to this calibration was within range, it was assumed that the controls had also slightly evaporated and therefore the results were within range.

• Brand Name: ISE INDIRECT K+ FOR GEN.2
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• 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: 6773237
• MDR Text Key: 82656856
• Report Number: 1823260-2017-01641
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

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: 10825441001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 09/06/2017
• 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
• Patient Age: 79 YR