MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-21

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.

Event Description

The customer reported a falsely elevated architect calcium result.Sample id ia0900329ss generated an initial result of 10.92 meq/l.The sample was retested multiple times ranging from 3.51 meq/l to 4.98 meq/l.The customer uses a normal range of 4.09 to 5.58 meq/l.No specific patient information was provided.No adverse impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Update 04dec2018: section, catalog # updated to 03l79-21.

Manufacturer Narrative

Review of the complaint activity for the calcium assay did not identify atypical complaint activity.The customers instrument logs were reviewed.This review found the customer does not perform all the required maintenance on the architect c8000 analyzer.During the review no identifiable quality control sample analysis was found.The lack of routine instrument maintenance and quality control testing may have contributed to the customers issue.Manufacturing documentation for the calcium assay did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customers issue.No systemic issue or deficiency of the architect calcium assay was identified.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8006894
• MDR Text Key: 125913676
• Report Number: 1628664-2018-01972
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• 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,Followup
• Report Date: 01/17/2019

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: 02/27/2019
• Device Catalogue Number: 03L79-21
• Device Lot Number: 98314UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 11/12/2018; 01/09/2019
• Supplement Dates FDA Received: 12/04/2018; 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000, LIST 01G06-11; ARCHITECT C8000, LIST 01G06-11; ARCHITECT C8000, LIST 01G06-11; SERIAL C802810; SERIAL C802810; SERIAL C802810