MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	07P9930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contact phone does not contain enough spaces, the entire phone (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account stated a false elevated alinity c creatinine result was generated on a patient sample that repeated lower.The patient serum sample tested alinity c creatinine of 14.5 mg/dl which was questioned as too high by a physician.The sample repeated slightly lower than 1 mg/dl.No specific patient information was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
A ticket search by product lot number was not performed as the lot number was unknown.The trend review by complaint list number found no adverse trends.No return sample available for testing.No testing performed on a file sample of the creatinine reagent.Review of the corrective and preventive actions system found no issue related to the current complaint.Labeling was reviewed and was found to adequately address the issue under review.The trend reviews did not identify an increase in complaint activity for the current issue.The sample when repeated generated result in the normal range, slightly lower than 1 mg/dl.The original result issue is determined to be sample related.No product deficiency was identified.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13573575
• Report Number: 3002809144-2022-00061
• Device Sequence Number: 5527056
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC03261; ALNTY C PROCESSING MODU, 03R67-01, AC03261
• Patient Sex: Unknown