MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C502

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for seven patient samples tested with albt2 tina-quant albumin gen.2.Samples were tested either on cobas 8000 c 502 module serial number (b)(4) (line 1), c 502 serial number (b)(4) (line 2), or both systems.Samples were initially tested either on (b)(6) 2022 or (b)(6) 2022.For the first sample, it was asked, but it is not known if any incorrect results were reported outside of the laboratory.Questionable results were reported outside of the laboratory for the remaining samples.This medwatch will apply to c 502 serial number (b)(4) (line 2).Please refer to the medwatch with patient identifier (b)(6) for information related to c 502 serial number (b)(4) (line 1).The first sample initially resulted in a microalbumin value of 1.8 ug/ml with a data flag when tested on line 2.The sample was repeated on line 1, resulting in a value of 461 ug/ml.The sample was also sent to a second site where it was tested on a cobas 6000 c (501) module, resulting in a value of 378 ug/ml.The result from the c 501 analyzer was deemed correct.The second sample initially resulted in a microalbumin value of < 5.7 ug/ml with a data flag when tested on line 1 and was reported outside of the laboratory as < 12 ug/ml.The sample was repeated on line 2, resulting in a value of 45.9 ug/ml.The sample was also sent to a second site where it was tested on the c 501 analyzer, resulting in a value of < 12 ug/ml.The result from the c 501 analyzer was deemed correct.The third sample initially resulted in a microalbumin value of < 1.8 ug/ml with a data flag when tested on line 1 and was reported outside of the laboratory as < 12 ug/ml.The sample was repeated on line 2, resulting in a value of 35 ug/ml.The sample was also sent to a second site where it was tested on the c 501 analyzer, resulting in a value of < 12 ug/ml.The result from the c 501 analyzer was deemed correct.The fourth patient sample initially resulted in a microalbumin value of 22 ug/ml when tested on line 2.The sample was sent to a second site where it was tested on the c 501 analyzer, resulting in a value of < 12 ug/ml with a flag.The result from the c 501 analyzer was deemed correct.The fifth patient sample initially resulted in a microalbumin value of 76.1 ug/ml when tested on line 1 on (b)(6) 2022.The sample was repeated on line 1 on (b)(6) 2022, resulting in a value of < 3.2 ug/ml with a flag.The sample was repeated on line 2 on (b)(6) 2022, resulting in a value of < 3.1 ug/ml with a flag.The sample was sent to a second site where it was tested on the c 501 analyzer either on (b)(6) 2022 or (b)(6) 2022, resulting in a value of < 12 ug/ml.The result from the c 501 analyzer was deemed correct.The sixth patient sample initially resulted in a microalbumin value of 59.9 ug/ml when tested on line 1 on (b)(6) 2022.The sample was repeated on line 1 on (b)(6) 2022, resulting in a value of < 11.7 ug/ml with a flag.The sample was repeated on line 2 on (b)(6) 2022, resulting in a value of 27.6 ug/ml.The sample was sent to a second site where it was tested on the c 501 analyzer either on (b)(6) 2022 or (b)(6) 2022, resulting in a value of < 12 ug/ml.The result from the c 501 analyzer was deemed correct.The seventh patient sample initially resulted in a microalbumin value of < 11.7 ug/ml with a flag.The sample was repeated on line 2, resulting in a value of 27.6 ug/ml.The sample was sent to a second site where it was tested on the c 501 analyze, resulting in a value of < 12 ug/ml.The result from the c 501 analyzer was deemed correct.The microalbumin reagent lot number was 64170601, with an expiration date of 29-feb-2024.

Manufacturer Narrative

The field service engineer determined that the line 2 sample probe caused the issue.The probe was replaced.A hardware check and precision studies were performed.The customer ran calibration and controls.

Manufacturer Narrative

The correct data for the first sample is as follows: the first sample initially resulted in a microalbumin value of 44.1 ug/ml with a data flag when tested on line 1.This sample was automatically repeated on line 1, resulting in a value of 461 ug/ml.The sample then repeated as 1.8 ug/ml with a data flag when tested on line 2.The sample was also sent to a second site where it was tested on a cobas 6000 c (501) module, resulting in a value of 378 ug/ml.The result from the c 501 analyzer was deemed correct.For line 2, the last microalbumin calibration performed on (b)(6)-2022 was ok and there were no alarms.For line 2, microalbumin quality controls were within range, showing no indication of a reagent performance issue.Upon review of the alarm trace for line 2, abnormal aspiration alarms and sample clot detection alarms occurred.These are indicators of possible poor sample quality.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 C 502 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15538494
• MDR Text Key: 302587992
• Report Number: 1823260-2022-03056
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: C502
• Device Catalogue Number: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• 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
• Patient Sequence Number: 1