MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS ALERE AFINION AS100 ANALYZER

Model Number 1115175

Device Problems Smoking (1585); Sparking (2595); Noise, Audible (3273)

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

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device requested, but not yet returned.

Event Description

On (b)(6) 2023 a customer phoned technical services (ts) to report seeing a spark when plugging in their afinion as100 analyzer with serial number (b)(4).Power cord was plugged into main wall outlet.Customer was unable to provide software version as the machine was not plugged in.Technical services asked intake questions as per d10035781 af and noted no deviations.No injuries occurred.

Manufacturer Narrative

The complaint details were reviewed along with internal records and no nonconformances were identified.There were no adverse patient effects and no clinically significant delay in the procedure reported in the complaint.Our investigation determined that there is no indication that the reported issue is related to product results, inadequate instructions for use or inaccurate labeling.Customer complaints will continue to be monitored to ensure control limits are not exceeded and ensure product's performance meets customers' expectations.Updates to the supplement: d4: lot number added h6: medical device problem code, component code, type of investigation and investigation conclusions, all updated from initial report.H3 other text : device has been requested, however has not been returned.

Event Description

On 10 feb 2023 a customer phoned technical services (ts) to report seeing a spark when plugging in their afinion as100 analyzer with serial number (b)(6).Power cord was plugged into main wall outlet.Customer was unable to provide software version as the machine was not plugged in.Technical services asked intake questions as per (b)(4) af and noted no deviations.No injuries occurred.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: claire dora ; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504
• MDR Report Key: 16501576
• MDR Text Key: 311054721
• Report Number: 9613069-2023-00002
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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 Model Number: 1115175
• Device Catalogue Number: 1115175
• Device Lot Number: 10175122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1