MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; CALCIUM TEST SYSTEM

Catalog Number	08057427190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results of 1 pediatric patient sample tested for calcium gen.2 (ca2) on a cobas pro c 503 analytical unit.The initial result from a micro cup was 2.75 mmol/l.The sample was repeated 3 times and a data flag was received with no numeric result.The sample was repeated again with a result of 2.29 mmol/l.On (b)(6) 2023 the sample was repeated with no new centrifugation performed and the result was 2.36 mmol/l.No questionable results were reported outside of the laboratory.The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
H3 other text : na.
Additional Manufacturer Narrative
The customer repeated the sample as the laboratory repeats samples with initial calcium results above 2.5 mmol/l.
Additional Manufacturer Narrative
Quality controls recovered within range.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: CALCIUM GEN.2
• Common Device Name: CALCIUM TEST 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17021824
• Report Number: 1823260-2023-01779
• Device Sequence Number: 7554907
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 05/31/2024
• Device Catalogue Number: 08057427190
• Device Lot Number: 70571101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/05/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown