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

Model Number	3L79-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2021
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.Patient identifier complete sid:(b)(6).
Event or Problem Description
The customer reported a falsely decreased calcium result generated on the architect c8000 analyzer on one patient.Results provided: (b)(6) 2021 sid (b)(6) = 2.9 mg/dl, sample redrawn = 9.3 mg/dl.Normal range: 8.5-10.5 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
H6.Health effect impact code: f26 component code: g01003 d8.Was this device service by a third party? no a review of tickets determined that there is normal complaint activity for lot number 68824un20.Trending review of list number 3l79 determined no trends for false low patient results due to the product.Return testing was not completed as returns were not available.Quality control results recovered in range.Precision run had no issues with quality control or any patient results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of architect calcium reagent (ln 3l79-32) lot number 68824un20 was identified.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11247421
• Report Number: 3002809144-2021-00066
• Device Sequence Number: 3502222
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

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: 07/14/2021
• Device Model Number: 3L79-32
• Device Catalogue Number: 03L79-32
• Device Lot Number: 68824UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 06/15/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/05/2021; 06/17/2021
• 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 C8 PROC MOD, 01G06-11, C802847; ARC C8 PROC MOD, 01G06-11, C802847; ARC C8 PROC MOD, 01G06-11, C802847