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

Model Number	3L79-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated calcium results generated on all three architect c8000 processing modules when changing to a new lot.The following data was provided (customer normal range 2.1 to 2.6 mmol/l): sid (b)(6), architect results >6.00 / 3.48 / 5.49 mmol/l, repeated on the roche platform 2.48 mmol/l.No adverse impact to patient management was 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.Review of complaint and trending data identified an increase in complaint activity related to the complaint issue.However no adverse trends were identified.Review of the complaint text indicated a smartwash was added to the configuration of the system configuration for the calcium assay which resolved the issue.A review of labeling addresses the customer issues.Additionally, product information provided to the customer indicated that reagent lots containing the new arsenazo dye lot may show an upward shift in qc and patient results.However, the internal studies indicate that the lots meet reagent release specifications.Based on this investigation, no deficiency of the calcium reagent was identified.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12469034
• Report Number: 3002809144-2021-00569
• Device Sequence Number: 20056694
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 11/11/2021

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: 06/29/2022
• Device Model Number: 3L79-32
• Device Catalogue Number: 03L79-32
• Device Lot Number: 88035UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 C8000 PRC MOD, 01G06-01, (B)(4); ARC C8000 PRC MOD, 01G06-01, (B)(4); ARC C8000 PRC MOD,01G06-01, (B)(4); ARC C8000 PRC MOD,01G06-01,(B)(4); ARC C8000 REFURB-SEKAT, 01G06-97, (B)(4); ARC C8000 REFURB-SEKAT, 01G06-97, (B)(4)
• Patient Sex: Unknown