MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Catalog Number	06L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
While using the clinical chemistry total bilirubin assay, the customer indicated that decreased bilirubin results were generated after calibration was completed with a new lot of calibrator.The customer provided the following data for an adult patient (provided reference range 3 - 21 umol/l): note: the retest results were generated after calibration was completed with new lot of calibrator.The customer indicated the initial results were considered correct.Sid (b)(6), initial 10.7, after retest 7.0, sid (b)(6), initial 5.4, retest 3.0, sid (b)(6), initial 9.3, retest 4.9, sid (b)(6), initial 7.0, retest 3.3, sid (b)(6), initial 7.1, retest 4.1, sid (b)(6), initial 10.6, retest 5.3, sid (b)(6), initial 13.2, retest 9.3, sid (b)(6), initial 17.9 , retest 11.4, sid (b)(6), initial 26.6 , retest 20.4, sid (b)(6), initial 21.1, retest 13.2.There has been no impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a batch record review, a search for similar complaints, in-house testing, and a review of labeling.Return material was not available.No issues were identified which would indicate a product deficiency from the batch record review.Product testing was completed; quality control samples, with expected recovery ranges, were tested using the total bilirubin reagent calibrated with bilirubin calibrator lot which was in use when the deceased patient results were generated.The controls generated results within the respective expected ranges; however, the results for the bio-rad lyphochek controls were observed to be within the low end of the expected ranges.The pooled serum was tested for information only and generated the same mean result across all systems.A review of tracking and trending identified an increase in complaint activity.However, no adverse trends or non-conformances for the issue observed by the customer were identified.Labeling was reviewed and found to be adequate; troubleshooting information intended to assist the operator with investigation of control results out of range for photometric assays is documented in labeling.Based on the available information no deficiency of the clinical chemistry bilirubin assay, list number 06l45 was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8527450
• Report Number: 1628664-2019-00318
• Device Sequence Number: 19324247
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (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): 06/05/2019

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: 06/30/2020
• Device Catalogue Number: 06L45-41
• Device Lot Number: 54494UQ01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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 C8000 PRCOCESS MODULE; ARCHITECT C8000 PRCOCESS MODULE; LN 01G06-01, SN (B)(4); LN 01G06-01, SN (B)(4)