MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ALINITY C CALCIUM

Catalog Number 07P57-20

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is completed.

Event Description

The account generated false elevated alinity c calcium of 3.7, 2.6 mmol/l that repeated 2.0, 1.9, 2.0, 2.0 mmol/l on the same and other analyzers with sample id (b)(6).The account uses a normal range of 2.1 to 2.55 mmol/l.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The initial report was submitted under manufacturer report number (irving, tx, usa as manufacturing site).Upon retrospective review, it was discovered that section d3 and g2, was incorrect.A new initial report was created to correct the site of manufacturer (wiesbaden, germany) under manufacturer report number 3002809144-2019-00491.All further information will be submitted under manufacturer report number 3002809144-2019-00491.No further followup under this manufacturer report number.

• Brand Name: ALINITY C CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8828397
• MDR Text Key: 152811935
• Report Number: 1628664-2019-00525
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• 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: 08/08/2019

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 Catalogue Number: 07P57-20
• Device Lot Number: 63032UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C LIST 03R67-01; ALINITY C LIST 03R67-01, SERIAL (B)(6); SERIAL (B)(6)