MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect calcium result on the architect c16000 analyzer.The sample generated an initial result of 4.93 mmol/l and retest generated 2.23 mmol/l.The customer uses a normal range of 2.20 to 2.60 mmol/l.No specific patient information was provided.
Additional Manufacturer Narrative
The customer's system logs were reviewed which found the r1 probe had low pressure outside of specification.The maintenance log also showed the quarterly maintenance was over-due.The field service engineer (fse) inspected the analyzer and replaced the poppet valves and bellows as a precaution.The troubleshooting performed on the analyzer did not identify a conclusive cause.Review of complaint activity determined that there is normal complaint activity for likely cause lot 97158un17.Tracking and trending report review for the architect calcium assay determined that there are no related adverse or non-statistical trends.World wide field data for the calcium assay was reviewed.The calcium patient population result medians were similar across multiple customers, instruments and reagent lots.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: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7562296
• Report Number: 1628664-2018-00217
• Device Sequence Number: 2044182
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2018
• Device Catalogue Number: 03L79-31
• Device Lot Number: 97158UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1