MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 01G06-11

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The customer observed falsely decreased calcium results generated on the architect c8000 processing module for one sample.The following example result was provided: (b)(6) 2024 (b)(6) original result was 5.8 mg/dl, repeat result was 8.4 mg/dl (repeated on same analyzer) no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 patient identifier complete information: (b)(6) all available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased calcium results generated on the architect c8000 processing module for one sample.The following example result was provided: 14mar2024 sid(b)(6)original result was 5.8 mg/dl, repeat result was 8.4 mg/dl (repeated on same analyzer) no impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument, performed troubleshooting procedures including replacement of the pump, probe wash, bellows type (rohs).The part replacement resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.The pump, probe wash, bellows type (rohs) was determined to be the likely cause of the issue.Review of all the information provided by the customer was reviewed.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.A review of tracking and trending did not identify any trends for the pump, probe wash, bellows type (rohs).Review of the clinical chemistry systems product monitoring review scorecard found no trends with regards to the current issue related to the architect system, likely cause part, or discrepant results as described in this ticket.The device history record review did not identify any non-conformances or any potential non-conformances.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module for serial number (b)(6)was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT C8000
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19031131
• MDR Text Key: 339228267
• Report Number: 3016438761-2024-00192
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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 Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CC CALCIUM, 03L79-42, 93049UN23; CC CALCIUM, 03L79-42, 93049UN23; PUMP, PROBE WASH, BELLOWS TYPE (ROHS), 7-204102-01; PUMP, PROBE WASH, BELLOWS TYPE (ROHS), 7-204102-01