MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number 03L79-31

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 further patient information was provided.

Event Description

The customer reported falsely elevated architect calcium results for a (b)(6) year old female patient.The sample generated architect results of 3.09, 3.96 and 3.17 mmol/l.The sample was retested on the mindray bs-2000m and generated normal results of 2.71 and 2.74 mmol/l.The sample was recentrifuged and retested on the architect generating 2.53 and 2.60 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

Architect c1600 was corrected to architect c16000.Review of complaint activity for reagent lot 15805un17 identified other complaints related to erratic results.However, tracking and trending report review for the architect calcium assay determined that there were no related trends.Review of the complaint text and results associated with the questioned sample found consistent results were obtained after the sample was re-centrifuged and controls were in range.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect calcium assay was identified.

• Brand Name: CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8918398
• MDR Text Key: 177809111
• Report Number: 1628664-2019-00580
• 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: 11/15/2019

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: 03L79-31
• Device Lot Number: 15805UN17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C1600, LIST 03L77-01,; ARCHITECT C16000, LIST 03L77-01,; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 7 YR