MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	02P24-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2018
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.An evaluation is in process.
Event or Problem Description
The customer observed multiple falsely elevated results while using clinical chemistry magnesium reagents.The following data was provided for one patient.(b)(6), initial 5.4 meq/l, repeat 1.2 meq/l; (b)(6), initial 6.1 meq/l, repeat 1.4 meq/l; (b)(6), initial 6.1 meq/l, repeat 1.6, 1.5 meq/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An abbott field service representative was dispatched to the account and found both analyzer cuvette nozzles were overflowing.The wash nozzle [hcw wsh nzl to hcw pump in part 7-205611-01] was replaced to resolve the issue.No additional discrepant magnesium results were reported and this part was considered the likely cause of the issue.Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument log review, instrument service review, and labeling review.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Service history review identified no contributing factors to the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.During issue evaluation, the suspect product was determined to be the analyzer.Suspect medical device information was updated to reflect change in section 4.Catalog number and lot number to the analyzer ln 02p24-40 sn (b)(6) from the reagent ln 07d70-21 ln 99639un18.Both products have the same medical device manufacturer.Concomitant medical products was changed to clinical chemistry magnesium ln 07d70-21 ln 99639un18 from architect c4000 ln 02p24-40 sn (b)(4).

• Brand Name: ARCHITECT C4000 ANALYZER
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7754305
• Report Number: 1628664-2018-01247
• Device Sequence Number: 19253224
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 02P24-40
• Device Lot Number: 99639UN18
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C4000 ANALYZER; CLINICAL CHEMISTRY MAGNESIUM; LN 02P24-40 SN C401619; LN 07D70-21 LN 99639UN18