MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-31

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Evalulation is in process.Follow up report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated architect calcium of 3.99 mmol/l when processing on the architect c8000.The sample repeated architect calcium of 2.34 mmol/l.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The customer replaced the sample and r1 probes on the architect c8000 analyzer.No customer returns were available for evaluation.A search of the complaint database by product lot number found other tickets similar to this issue.These tickets were closed with no deficiency found.The trend review by the product list numbers found no adverse or non-statistical trends related to this issue.Review of patient data in the field shows the calcium patient population result medians are similar for each product across multiple customers, instruments, and reagent lots.Review of product labeling revealed adequate labeling for the handling of reagents, handling of patient samples, interpretation of assay results, and troubleshooting this complaint issue.No deficiency 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: 7732985
• MDR Text Key: 115526849
• Report Number: 1628664-2018-00785
• 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: 09/27/2018

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: 10/27/2018
• Device Catalogue Number: 03L79-31
• Device Lot Number: 45322UN17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/27/2018
• 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; SERIAL (B)(4); SERIAL (B)(4)