MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 SENSOR GLU/LAC/UREA; ACID, LACTIC, ENZYMATIC METHOD

Catalog Number 03261085184

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they have been having ongoing issues with the glucose and lactate tests when testing patient samples using the cobas b 221 sensor glu/lac/urea on a cobas b 221 analyzer.The control performance is erratic and there is lack of result reproducibility.The field service engineer has performed extensive troubleshooting with the analyzer in order to address the issue.The customer provided data for one patient with erroneous lactate test results.The erroneous results were reported outside of the laboratory.A sample from the patient resulted with a lactate value of 4.8 mmol/l.One hour later, a sample from this patient resulted with a lactate value of 5.6 mmol/l.Two hours later, a sample from this patient resulted with a lactate value of 1.6 mmol/l.The results did not fit the clinical picture of the patient as the patient was believe to still be acidotic.No adverse events were alleged to have occurred with the patient.The serial number of the cobas b 221 analyzer is (b)(4).The field service engineer moved the system to a different location and updated communication settings on the system.He replaced an electrode, the cobas b 221 sensor glu/lac/urea, a system reagent, and tubing as a precaution.He ran calibration and there were issues with the calibration.He then ran wetting maintenance routines and repeated calibration.The calibration was ok.The customer ran controls and one level was outside of range.

Manufacturer Narrative

The complained sensor lot 21590148 was inserted in the analyzer on (b)(6) 2019.During the first hours, significant drift was noted for one level of calibrator for the glucose sensor was detected, but values were still within specifications.After approximately 12 hours, the sensor stopped drifting and the calibration signals of all calibrator levels were stable throughout the entire period of time.The complained measurements took place on (b)(6) 2019.Control measurements performed before the event were acceptable.A microscopic visual inspection of the complained sensor was performed and the latex membranes were dispensed appropriately.No visible defects of the latex membranes were detected.There was no evidence the complained measurements were the consequence of a sensor or instrument issue.Based upon provided data, there were several issues with the complained patient sample as there were extremely abnormal values for many parameters.A sample related issue is suspected.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 221 SENSOR GLU/LAC/UREA
• Type of Device: ACID, LACTIC, ENZYMATIC METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8499992
• MDR Text Key: 141482467
• Report Number: 1823260-2019-01415
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Catalogue Number: 03261085184
• Device Lot Number: 21590148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1