MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Model Number	6L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a falsely elevated architect total bilirubin result of 14.5 mg/dl was generated.Sid (b)(6).(b)(6), 2023.Patient age: 34 hours.Initial result: 14.5 mg/dl at 4:42 a.M.Normal range: 0.1 - 10.3 mg/dl.The patient was put under a photo blanket for 2 hours.A new sample from the patient was tested at 6:02 p.M.Generating a result of 4.3 mg/dl.The initial sample was then retested.Same c8000 analyzer (serial number (b)(6)) result of 6.1 mg/dl.Different c8000 analyzer (serial number (b)(6)) result of 5.9 mg/dl.The redrawn sample was retested.Same c8000 analyzer (serial number (b)(6)) result of 4.5 mg/dl.Different c8000 analyzer (serial number (b)(6)) result of 4.3 mg/dl.The customer stated there was no harm to the patient.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.The sample in question was retested by the customer and gave an acceptable result.In addition, quality control was performing as expected.No additional issues were identified.Based on the investigation, no deficiency for lot number 63184uq11 was identified.
Event or Problem Description
The customer stated that a falsely elevated architect total bilirubin result of 14.5 mg/dl was generated.Sid (b)(6) june 24, 2023 patient age: 34 hours initial result: 14.5 mg/dl at 4:42 a.M.Normal range: 0.1 - 10.3 mg/dl the patient was put under a photo blanket for 2 hours.A new sample from the patient was tested at 6:02 p.M.Generating a result of 4.3 mg/dl.The initial sample was then retested.Same c8000 analyzer (serial number (b)(6)) result of 6.1 mg/dl.Different c8000 analyzer (serial number (b)(6)) result of 5.9 mg/dl the redrawn sample was retested.Same c8000 analyzer (serial number (b)(6)) result of 4.5 mg/dl.Different c8000 analyzer (serial number (b)(6)) result of 4.3 mg/dl the customer stated there was no harm to the patient.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 17318272
• Report Number: 3002809144-2023-00307
• Device Sequence Number: 6115782
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/15/2023

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 Expiration Date: 04/30/2024
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 63184UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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: ARC C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Age: 2 DA
• Patient Sex: Unknown