MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Model Number	04V5121
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Hyperbilirubinemia (1903)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information is included.Additional patient details are not available.(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated alinity c total bilirubin result for a newborn that was born on (b)(6) 2022 (4 days old at time of incident).The following information was provided (customer¿s reference range: 205-340 umol/l patient is to be monitored, > 340 umol/l phototherapy at the hospital).On (b)(6) 2022 the patient generated a total bilirubin result of 350.8 umol/l.For this result the laboratory recommended phototherapy and therefore hospitalization.The customer was unable to obtain any further information about the patient and it is unknown if the patient was actually hospitalized and given phototherapy treatment.The sample was tested using the roche cobas technique and generated a result of 270 umol/l.This result did not meet the threshold of receiving phototherapy but ¿to be monitored¿.The customer rechecked the sample on (b)(6) 2022 and generated a total bilirubin result of > 427.5 umol/l on the alinity c processing module.There is no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c total bilirubin results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search by product lot number found normal complaint activity.A review of tracking and trending did not identify any related trends for the product for the issue.A review of the device history records did not identify any non-conformances or deviations for lot number 62045uq04 and complaint issue.The historical performance of reagent lot 62045uq04 was evaluated using world-wide data from customers in the field.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 62045uq04 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 59764uq05.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for alinity c total bilirubin reagent lot 62045uq04.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• 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: 15953299
• Report Number: 3002809144-2022-00427
• Device Sequence Number: 12619187
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 09/30/2023
• Device Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Device Lot Number: 62045UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC03441; ALNTY C PROCESSING MODU, 03R67-01, AC03441
• Patient Age: 4 DA
• Patient Sex: Unknown