MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Model Number	3L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that an initial creatinine result of 2.3 mg/dl was generated on the architect c4000 analyzer.The result was questioned by the physician.A new sample was obtained and a result of 1.0 mg/dl was generated.The customer repeated both samples and results of 1.0 and 1.1 mg/dl were generated.There was no report of impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the customer's issue was is not associated with the clinical chemistry creatinine reagent list number 03l81-22 lot 06816un17.The suspect device is the architect c4000 analyzer and all further information will be documented under manufacturer report number 1628664-2018-00157.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7452974
• Report Number: 1628664-2018-00156
• Device Sequence Number: 107286
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: (01)00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 06816UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C4000 ANALYZER 02P24-40; ARCHITECT C4000 ANALYZER 02P24-40; SN (B)(4) ; SN (B)(4)