MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY C PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03R67-01

Device Problem Leak/Splash (1354)

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

Event Date 08/20/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The abbott field service representative (fse) was spashed in the right eye with dirty water while working on the alinity c analyzer, serial number ac1418.The fse flushed eye with saline and was able to continue working with no further treatment.No further impact to patient management was reported.

Manufacturer Narrative

A field service engineer (fse) was sprayed in the eye with dirty water, when investigating a water leak from the rear fitting, exterior drain hcw (rohs) on the alinity c, serial (b)(6) , and the tubing popped off when the module was in process.The fse was not wearing proper eye protection(proper protection equipment-ppe).The fse immediately cleaned the eye with a saline solution, no additional treatment was given.The fitting, exterior drain hcw (rohs)_part number 7-202645-01 was cleaned, and cable ties/clamps were placed, resolving the issue.An instrument service history review for alinity (b)(6) revealed no contributing factors on or around the date of the complaint.There have been no subsequent contacts from the customer regarding splashing occurrence since the reported incident.A review of tracking and trending of the alinity c/clinical chemistry system did not identify any trends associated with the complaint issue.A review of tracking and trending for the fitting, exterior drain hcw (rohs)_part number 7-202645-01 did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.The alinity ci-series operations manual addresses operator responsibility and biological and chemical safety hazards that include wearing personal protective equipment (ppe) and safety awareness where hazards may exist.Based on the available information, no systemic issue or deficiency of the alinity c, serial (b)(6) or the fitting, exterior drain hcw (rohs)_part number 7-202645-01 was identified.Section g1 contact information was updated to reflect the current contact (b)(6).

Event Description

The abbott field service representative (fse) was spashed in the right eye with dirty water while working on the alinity c analyzer, serial number (b)(6).The fse flushed eye with saline and was able to continue working with no further treatment.No further impact to patient management was reported.

• Brand Name: ALINITY C PROCESSING MODULE
• 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: 17642244
• MDR Text Key: 322178444
• Report Number: 3016438761-2023-00453
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: 00380740137380
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILTER, WATER BATH, C-35016361-01, UNKNOWN; FILTER, WATER BATH, C-35016361-01, UNKNOWN