MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Model Number	C311
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for altl alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation (altl) on a cobas 4000 c (311) stand alone system compared to the siemens dimension rxl max method."patient 2" initial result from the c311 system was 6.1 u/l.The result from the siemens method was 22 u/l.On (b)(6) 2021 "patient 3" initial result from the c311 system was 20.1 u/l.The result from the siemens method was 32 u/l.No questionable results were reported outside of the laboratory.The c311 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
The altl reagent lot number was 54341101 with an expiration date of 30-jun-2022.The suspect medical device was updated.The applicable fields of sections d and g were updated.The field service engineer (fse) found the water conductivity was 8.6 (units not provided); the filter was replaced and recalibration was performed.Per product labeling, the water conductivity should not be more than = 1.0 s/cm.The customer had no further issues after the service visit.The customer used a centrifugation time of 4 minutes at 4200 rpm.Based on the type of sample tubes the customer uses, this is not the recommended time.The customer does not use additive tubes.Based on the serum tubes the customer uses, the recommended clotting time is 90 minutes under room temperature; the customer used a clotting time of 10 minutes.Based on the data provided, a general reagent problem has been excluded as calibration and qc were acceptable.The investigation determined the event was consistent with pre-analytical handling issues at the customer site.

• Brand Name: COBAS 4000 C (311) STAND ALONE SYSTEM
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12206198
• Report Number: 1823260-2021-02123
• Device Sequence Number: 14598822
• Product Code: JJE
• UDI-Device Identifier: 04015630913862
• UDI-Public: 04015630913862
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: C311
• Device Catalogue Number: 04826876001
• Device Lot Number: 54341101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1