MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I PROCESSING MODULE; AUTOMATED IMMUNOASSAY ANALYZER

Model Number 03R6501

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.

Event Description

An abbott field service representative reported while removing an external pump from the alinity i processing module he spilled liquid on his right hand.His glove was torn, and liquid got on his hand where some skin was broken.He provided that the area was washed, and no bandaging or treatment was required.He did advise serological blood tests were performed following the incident.

Manufacturer Narrative

Evaluation results: the evaluation of the issue of a service representative who had a scratch his hand and spilled waste on it while changing out of parts on the alinity i (b)(6) could not rule out user error.The evaluation included a review of the (b)(6) service history and did not identify any additional injury or exposure.Product labeling was reviewed and fund to be adequate.No similar issues as described in this complaint, nor was a trend identified with respect to spills.No trend or systemic issue was observed for the alinity i.

• Brand Name: ALINITY I PROCESSING MODULE
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10093527
• MDR Text Key: 199671041
• Report Number: 3002809144-2020-00416
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: 00380740137366
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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: Other
• Device Model Number: 03R6501
• Device Catalogue Number: 03R65-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1