MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account questioned elevated architect calcium results on a patient who was expected to test in the normal range.The patient tested architect calcium of 2.48 mmol/l ((b)(6) 2017), 3.66 mmol/l ((b)(6) 2017) and 3.23 mmol/l ((b)(6) 2017).The samples were repeated on another architect analyzer with similar results.The account uses the package insert normal range for calcium.No impact to patient management was reported.

Manufacturer Narrative

Review of complaint activity determined that there is only one other complaint related to discrepant results for likely cause lot 36254un16.Tracking and trending report review for the architect calcium assay determined that there are no related adverse or non-statistical trends.Manufacturing release documents were reviewed and show this reagent lot met specifications prior to release.Labeling was reviewed and sufficiently addresses the customer's issue.A product deficiency was not identified.However, based on the available information within the complaint record, the device failed to meet performance specifications or otherwise perform as intended at the customer site.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6632069
• MDR Text Key: 77524112
• Report Number: 1628664-2017-00249
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: (01)00380740005931(17)171219(10)36254UN16
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K981578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

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: 12/19/2017
• Device Catalogue Number: 03L79-21
• Device Lot Number: 36254UN16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR