MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CLINICAL CHEMISTRY CALCIUM

Model Number 3L79-31

Device Problem High Test Results (2457)

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

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer due to privacy issues.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated calcium results on architect c16000 processing module for one patient.The results provided were: on (b)(6) 2020 sid (b)(6) calcium results=3.09 mmol/l and 4.10 mmol/l/ results from another architect c1600561=2.29 mmol/l and 2.14 mmol/l /repeated on another architect c1600377=2.20 mmol/l and 2.18 mmol/l.There was no reported impact to patient management.

Manufacturer Narrative

A ticket search was performed for the architect calcium, reagent lot number 84863un19.An investigation was performed for the customer issue and included a review of the complaint text, a search for tracking and trending, a review of historical performance and product labeling.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the calcium assay, lot number 84863un19 was identified.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10333861
• MDR Text Key: 203887211
• Report Number: 3016438761-2020-00143
• 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
• Report Date: 08/07/2020

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: 02/10/2021
• Device Model Number: 3L79-31
• Device Catalogue Number: 03L79-31
• Device Lot Number: 84863UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM.; ARCHITECT C16000 SYSTEM.; LIST # 03L77-0, SERIAL # (B)(6).; LIST # 03L77-0, SERIAL # (B)(6).