MAUDE Adverse Event Report: ABBOTT LABORATORIES CALCIUM

Model Number	3L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported a falsely elevated calcium result for one patient on the architect analyzer, that upon repeat was within the normal range.Results provided for (b)(6): initial= 4.329 mmol/l, repeat= 2.40 mmol /l (normal range = 2.10 to 2.55 mmol/l); retested second time = 2.19mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
A review of tickets found no other tickets for lot 28794un19 similar to this complaint, and no trends for the issue for the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the architect system operations manual provides multiple probable causes and corrective actions for elevated concentration.Based on the investigation no product deficiency was identified for the calcium reagent, lot 28794un19.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9986024
• Report Number: 1415939-2020-00036
• Device Sequence Number: 3676042
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 10/01/2020
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 28794UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/25/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: ARCHITECT C16000 PROCESSING MODULE,; ARCHITECT C16000 PROCESSING MODULE,; LN 03L77-01, SN (B)(6) ; LN 03L77-01, SN (B)(6)