MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM

Catalog Number	03L79-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely depressed calcium (ca) result for a 41-year-old male patient when running on the architect c16000 processing module.The following data was provided: initial results (mmol/l): ca = 1.3.Repeat results (mmol/l) ca = 2.45.The customer¿s reference ranges were: ca: 2.11-2.52 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.As part of the troubleshooting the same sample was rerun on the same instrument and same reagent lots and generated higher results.The quality controls were performing within the expected ranges, which shows that the assays were performing as expected.A ticket search by lot number did not identify any increase in complaint activity that was related to the complaint issue.A review of ticket trending was performed, and no trends were identified that were related to the complaint issue.A review of the device history record did not identify any non-conformances or deviations related to the lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the clinical chemistry calcium reagent lot 46188un23 was identified.
Event or Problem Description
The customer reported a falsely depressed calcium (ca) result for a 41-year-old male patient when running on the architect c16000 processing module.The following data was provided: initial results (mmol/l): ca = 1.3.Repeat results (mmol/l).Ca = 2.45.The customer¿s reference ranges were: ca: 2.11-2.52 mmol/l.There was no impact to patient management reported.

• Brand Name: CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18632135
• Report Number: 3002809144-2024-00027
• Device Sequence Number: 8092168
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062855
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 08/01/2024
• Device Catalogue Number: 03L79-22
• Device Lot Number: 46188UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Age: 41 YR
• Patient Sex: Male