MAUDE Adverse Event Report: ABBOTT LABORATORIES CALCIUM

Model Number 3L79-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  malfunction  

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 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.

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
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9986024
• MDR Text Key: 226762450
• Report Number: 1415939-2020-00036
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (y/n): N
• PMA/PMN Number: K981578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/25/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 PROCESSING MODULE,; ARCHITECT C16000 PROCESSING MODULE,; LN 03L77-01, SN (B)(6) ; LN 03L77-01, SN (B)(6)