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	06/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated total bilirubin results for a newborn patient (30 hours old) who was treated with a photo blanket for 10 hours.On (b)(6) 2023 for sid (b)(6) the initial result was 19.7 mg/dl (sample integrity +1 hemolysis), the newborn was placed under the photo blanket.A new sample was recollected a couple of hours later and the result was 6.3 mg/dl (normal range 0.1 ¿ 10.3 mg/dl).The issue was discovered on (b)(6) 2023 but the sample was already discarded; unable to rerun tests.The newborn received treatment with a photo blanket for 10 hours.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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.Precision 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 observed falsely elevated total bilirubin results for a newborn patient (30 hours old) who was treated with a photo blanket for 10 hours.On (b)(6)2023 for sid (b)(6)the initial result was 19.7 mg/dl (sample integrity +1 hemolysis), the newborn was placed under the photo blanket.A new sample was recollected a couple of hours later and the result was 6.3 mg/dl (normal range 0.1 ¿ 10.3 mg/dl).The issue was discovered on (b)(6)2023 but the sample was already discarded; unable to rerun tests.The newborn received treatment with a photo blanket for 10 hours.No adverse impact to patient management was reported.

• 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: 17267587
• Report Number: 3002809144-2023-00302
• Device Sequence Number: 14923988
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/18/2023
• 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 C4 PROC MOD, 02P24-01, C461621; ARC C4 PROC MOD, 02P24-01, C461621
• Patient Age: 2 DA
• Patient Sex: Unknown