MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-17 for CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR 1E66-04 manufactured by Abbott Mfg, Inc..
[953404]
The customer stated they generated a neonate bilirubin result of 19 on the architect c8000. When the sample was rerun on another platform, the result was 15. The neonate was hospitalized at a different facility. In addition, the customer's (b)(6) samples have been recovering high. The customer has received the customer communication letter and believes the changes described will help. No evidence of further pt intervention has been reported.
Patient Sequence No: 1, Text Type: D, B5
[8215878]
Explanation of other conclusion: abbott clinical chemistry bilirubin calibrator - value assignment process was inadequate causing low and high results on pt samples and (b)(6) surveys. Abbott clinical chemistry bilirubin calibrator is used on the aeroset and architect csystem 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 pt 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 08/10/2007 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)(6). (b)(6) standard preparation was identified as a source of variability. The (b)(6) standard minimized lot-to-lot variability in the value assignment process. Following the use of verichem 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, and higher than expected pt results. An investigation was initiated for the total bilirubin reagents. The root cause was determined to be matrix issues for total bilirubin reagent (diazo) related to the commutability of various samples ((b)(6) standard, (b)(6) standard, bilirubin calibrator, and pt 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)(6) standard. The cause of this issue was confirmed through testing performed using an external reference jendrassic and groff 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 09/17/2008 (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)(6) standard preparation and increasing replicates to improving accuracy; revalidated the procedure. Reassigned of (b)(6) standards using in-house prepared (b)(6) standard to allow for less variability from one assignment to another. Assigned the values for bilirubin calibrator using reassigned (b)(6) standards by in-house prepared (b)(6) standards per jendrassic and groff method. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2008-00195 |
| MDR Report Key | 1203492 |
| Report Source | 05 |
| Date Received | 2008-10-17 |
| Date of Report | 2008-09-19 |
| Date of Event | 2008-09-12 |
| Date Mfgr Received | 2008-09-19 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2011-07-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. KHAUDEJA BANO |
| Manufacturer Street | 820 MISSION ST. D09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Manufacturer G1 | ABBOTT MFG, 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 | 2018433-09/19/08-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR |
| Generic Name | FOR USE IN THE CALIBRATION OF CC BILI |
| Product Code | JJB |
| Date Received | 2008-10-17 |
| Catalog Number | 1E66-04 |
| Lot Number | 57919M100 |
| Device Expiration Date | 2009-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MFG, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-10-17 |