MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-21
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.(b)(6).(b)(4).
Event or Problem Description
The customer reports the following patient architect clin chem calcium assay results generated on an architect c16000 analyzer: (b)(6).No suspect results were reported from the lab.There is no impact to patient management reported.
Additional Manufacturer Narrative
A review of complaint tracking and trending metrics was performed and identified no adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation.No non-conformances, deviations or potential non-conformances associated with the affected assay have been identified.There were no returns available from the customer site.A review of customer instrument logs found no evidence of any abnormalities that may have caused the reported issue.However, the assay graphs between the initial and retest results were very different.Also, numerous aspiration errors were noted.An occurrence of this error with no assignable instrument cause suggests an issue with sample handling and/or integrity.The history log shows occurrences of instrument hard stops after which the required cuvette washing was not allowed to occur (customer initiated).The architect clinical chemistry calcium (ca) assay package insert and the architect system operations manual contain information to address the current customer issue.Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest that a systemic issue or product deficiency exists.Use error may have contributed to the issue as it appears to be sample specific.The customer did mention that there may have been cells on top of the sample.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7008823
• Report Number: 1628664-2017-00429
• Device Sequence Number: 10886975
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2018
• Device Catalogue Number: 03L79-21
• Device Lot Number: 80658UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1