MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P612

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of questionable results on multiple tests performed on one patient sample aliquotted by a cobas p612 pre-analytical system and tested on a cobas 8000 analyzer.Of the results provided for eight tests, four were erroneous and reported outside the laboratory.Initial tests were run on the aliquot from the p612 on the cobas 8000 with serial number (b)(4).Repeat tests were run on the primary tube on the cobas 8000 with serial number (b)(4).A corrected report was issued.The sample was retested because the doctor questioned the initial sodium result from the aliquot.The initial sodium result was 117 mmol/l with a data flag.The analyzer reran the test with the same result.It was reported outside the laboratory.The repeat on the primary tube was 144 mmol/l.The initial potassium was 3.3 mmol/l with a repeat of 4.3 mmol/l.The initial chloride was 80 mmol/l with a repeat of 100 mmol/l.The initial calcium was 9.2 mg/dl with a repeat of 7.3 mg/dl.The customer repeated the sodium on the aliquot sample on analyzer (b)(4) (the analyzer on which the primary tube had been run) on (b)(6) 2017.The results were 119 mmol/l and 120 mmol/l, both with data flags, demonstrating the result on the aliquot was repeatable on a second analyzer.The patient was not adversely affected.The lot numbers of the reagents and electrodes involved were requested but not provided.The field service representative (fsr) could not find a cause for the event.He checked the p612 for leaks and proper alignments.All were good both before and after his actions.He found wear on a syringe and replaced it as a precaution.Operational and mechanical checks passed.

Manufacturer Narrative

The investigation determined that, since the difference in results between the primary tube and the aliquot were constant, the issue was due to a dilution of the aliquot.Additional data were requested for the investigation but were not available.The investigation was unable to determine a root cause with the information provided.

Manufacturer Narrative

Manufacturing site was corrected.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 6326162
• MDR Text Key: 67335630
• Report Number: 1823260-2017-00297
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/08/2017

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 Model Number: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided; 01/24/2017
• Supplement Dates FDA Received: 02/28/2017; 12/08/2017
• 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