MAUDE Adverse Event Report: ABBOTT LABORATORIES CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number 03L81-20

Device Problem Low Test Results (2458)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sids: are: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely decreased creatinine results generated on the architect c4000 analyzer for one hemodilution patient.A second sample was collected and retested.The customer believed the result from the second sample was correct as it correlated with the patient¿s clinical information.The following data was provided: first sample: sid: (b)(6) initial result = 0.86 mg/dl, repeat result = 1.57 mg/dl.Second sample: sid: (b)(6) result = 7.25 mg/dl no impact to patient management was reported.

Manufacturer Narrative

Additional information was received indicating the suspect medical device changed from creatinine (list number 03l81-20) to creatinine2 (list number 04s95-20).The creatinine2 (list number 04s95-20) does not have a same/similar product distributed in the us.Based on this new information, this complaint is no longer a mdr reportable event and no further information will be provided.

• Brand Name: CREATININE
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15481789
• MDR Text Key: 306418887
• Report Number: 3016438761-2022-00441
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K083809
• 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: 10/02/2022

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: 03L81-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/25/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C462273; ARC C4 PROC MOD, 02P24-01, C462273