MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2007-09-05 for CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR 1E66-04 manufactured by Abbott Manufacturing, Inc..
[8212045]
(b)(4), concomitant medical products: analyzer serial# (b)(4). Explanation of other conclusion: abbott clinical chemistry bilirubin calibrator value assignment process was inadequate causing low and high results on patient samples and (b)(4) surveys. Abbott clinical chemistry bilirubin calibrator is used on the aeroset and architect system to calibrate total and direct bilirubin. Abbott customers reported the following issues for clinical chemistry bilirubin calibrator: low bias for total bilirubin quality control (qc) and patient results with bilirubin calibrator lot number change. Results trending low with proficiency survey samples. Investigation of these issues determined that the calibrator values assigned to the total bilirubin reagent (list 6l45 and 8g62) caused results to trend downward over the past several calibrator lot numbers. With a change from calibrator lot 38436m100 to lot 41456m100 a bias of (-) 7% to 3% was observed. With a change from calibrator lot 38436m100 to lot 42396m100 a bias of (-) 4% to 2% was observed. With a change from calibrator lot 38436m100 to lot 48616m100 a bias of (-) 5. 5% to 3. 2% was observed. On (b)(4), 2007 a product correction letter (fa10aug2007) was issued to address bilirubin low recovery complaints and provided customers with new bilirubin values for all on-market calibrator lots. The new bilirubin values were assigned using the secondary standard (b)(4). (b)(4) standard preparation was identified as a source of variability. The (b)(4) standard minimized lot-to-lot variability in the value assignment process. Following the use of (b)(4) as a standard for the assignment for the bilirubin calibrator, an increase in customer complaints for high results for total bilirubin reagents (06l45 and 08g62) was observed: higher than expected results on proficiency survey samples. Higher than expected quality control (qc) recovery. Higher than expected patient results. An investigation was initiated for the total bilirubin reagents (ln 8g62 and ln 6l45) which determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the (b)(4) method in the abbott total bilirubin reagents (ln 8g62 and ln 6l45). The matrix of this secondary standard caused a positive bias. Because of these findings, a new total bilirubin calibrator value assignment process was implemented for use with the total bilirubin reagents. The revised values lowered total bilirubin results up to 18%. There is no established reference method for total bilirubin, however literature references document ongoing efforts of standardization. Abbott has selected a total bilirubin calibrator value assignment process used by the (b)(4) for neonatal proficiency survey samples. Accuracy of the new process was confirmed using the (b)(4). The improved value assignment procedure remains traceable to (b)(4) and demonstrates minimal sensitivity to matrix variability. Alignment of the standardization directly to the (b)(4) with confirmation of total bilirubin commutability to the (b)(4) method improves the value assignment accuracy. The root cause was determined to be matrix issues for total bilirubin reagent (b)(4) related to the commutability of various samples ((b)(4) standard, (b)(4) standard, bilirubin calibrator, and patient samples) due to the production materials used, e. G. Human serum albumin (hsa) vs. Bovine serum albumin (bsa). This matrix effect was responsible for the over-recovery observed by customers during the conversion to the (b)(4) standard. The cause of this issue was confirmed through testing performed using an external reference (b)(4) method. As a corrective/preventive measure all on-market bilirubin calibrator lots were re-value assigned per the new value assignment procedure providing improved accuracy for total bilirubin reagents. These values were communicated in the customer letter that was issued on (b)(4), 2008 (fa12sep2008 revision 01). In addition, abbott (b)(4) has re-written and validated the procedure for bilirubin calibrator. Value assignment and value verification that include: clarified procedure for primary (b)(4) standard preparation and increasing replicates to improving accuracy; revalidated the procedure. Reassigned of (b)(4) standards using in-house prepared (b)(4) standard to allow for less variability from one assignment to another. Assigned the values for bilirubin calibrator using reassigned (b)(4) standards by in-house prepared (b)(4) method. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[18241046]
The customer stated that the architect bilirubin control values have shifted (customer did not specify whether the controls shifted up or down. ). Customer also ran controls on another module and received the same results. This issue occurred after using new calibrators (lot# 41456m100). There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[18359485]
The is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00065 |
| MDR Report Key | 909285 |
| Report Source | 01,04 |
| Date Received | 2007-09-05 |
| Date of Report | 2007-08-09 |
| Date of Event | 2007-05-15 |
| Date Mfgr Received | 2008-09-25 |
| Device Manufacturer Date | 2006-06-29 |
| Date Added to Maude | 2008-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. KHAUDEJA BANO |
| Manufacturer Street | 100 ABBOTT PARK ROAD D09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-8/20/07-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR |
| Generic Name | FOR USE IN THE CALIBRATION OF THE CLINICAL CHEMISTRY BILIRUBIN ASSAY |
| Product Code | JFM |
| Date Received | 2007-09-05 |
| Model Number | NA |
| Catalog Number | 1E66-04 |
| Lot Number | 41456M100 |
| ID Number | NA |
| Device Expiration Date | 2007-12-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 891480 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-05 |