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

Catalog Number	02P24-01
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, patient identifier = initial sample (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.
Event or Problem Description
The customer reported a falsely elevated magnesium (mg) result generated on the architect analyzer for one patient.The results provided were: on (b)(6) 2018 (b)(6) mg = 6.4mg/dl / patient redrawn (b)(6) = 2.0mg/dl / then the customer retested the original sample 5x and results were 2.0 or 2.1mg/dl(normal range 1.6-2.6mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
Suspect medical device was changed from: clinical chemistry magnesium, list number 07d70-21, lot 33784un18, manufacturing site: (b)(4), to architect c4000 analyzer, list number 02p24-01, serial # (b)(4) with the same manufacturing site.The concomitant changed from architect c4000 analyzer; list # 02p24-01; serial # (b)(4), to clinical chemistry magnesium; list # 07d70-21; lot # 33784un18.The mdr number for this event remains the same [mdr # 1628664-2018-02031].The customer observed that the cuvette drying tip was dirty and ordered a replacement.Subsequent follow-up with the customer confirmed that no further discrepant results have been observed since the cuvette drying tip was replaced.A review of the architect, serial number (b)(4) instrument logs, confirm the pressure monitoring (pm) board was functional at the time of the event.A review of the sn (b)(4)service history found no additional contributing factors and no additional reports of discrepant or inconsistent results have been received.A review of complaints for the cuvette drying tip did not identify any trend or systemic issue.A review of tracking and trending for clinical chemistry systems (c4000, c8000, and c16000) revealed no issues or trends related to the current complaint.The architect system operations manual provides adequate information regarding handling samples, maintenance, component replacement, operational precautions and limitations of result interpretation, error codes, and troubleshooting the reported issue.Based on the investigation no product deficiency was identified for architect c4000, serial number (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: 8101465
• Report Number: 1628664-2018-02031
• Device Sequence Number: 13982857
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 06/11/2020
• Device Catalogue Number: 02P24-01
• Device Lot Number: 33784UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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, LIST # 02P24-01,; CLINICAL CHEMISTRY MAGNESIUM, LIST # 07D70-21,; LOT # 33784UN18; SERIAL # (B)(4)