MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-03 for CLINICAL CHEMISTRY PHOSPHORUS 7D71-21 manufactured by Abbott Manufacturing, Inc..
[1505423]
The customer stated the phosphorus calibration failed and the quality control was out of range low when using a new phosphorus reagent assay on the architect c8000 analyzer. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8652329]
(b)(4). Evaluation: insufficient aspiration of the r2 reagent. The clinical chemistry phosphorus reagent, list number 7d71-21 has demonstrated imprecision, primarily in the form of results with less than flags and in error code 3106/3103 (unable to process test, liquid contact broken during aspiration of reagent 2 pipettor). Additionally, there is a potential for falsely depressed patient values to be generated. The investigation has revealed the cause of this issue is related to the insufficient aspiration of the r2 reagent. In response to this issue a product recall was initiated. All current customers who have received clinical chemistry phosphorus, list number 7d71-21 of any lot, and have an architect c8000, architect c16000 or aeroset analyzer were instructed to discontinue use and destroy any remaining inventory. Replacement kits (7d71-31 or 7d71-22) were made available to replace 7d71-21. Product labeling was reviewed and found to adequately address the causes and corrections to error code 3103 and 3106, unable to process test, liquid contact broken during aspiration for reagent 2 pipettor. Additionally, when values less than the linearity or limit of detection are produced, the system generates a less than flag ( < ) to indicate to the operator that the result is outside the dynamic or linear range for the assay and should be reviewed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2010-00102 |
| MDR Report Key | 1709226 |
| Report Source | 05 |
| Date Received | 2010-06-03 |
| Date of Report | 2010-01-25 |
| Date of Event | 2010-01-25 |
| Date Mfgr Received | 2010-05-12 |
| Device Manufacturer Date | 2009-08-10 |
| Date Added to Maude | 2010-12-10 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-5/4/10-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY PHOSPHORUS |
| Generic Name | FOR THE QUANTITATION OF PHOSPHORUS IN HUMAN SERUM, PLASMA, OR URINE |
| Product Code | CEO |
| Date Received | 2010-06-03 |
| Catalog Number | 7D71-21 |
| Lot Number | 78059HW00 |
| Device Expiration Date | 2010-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-03 |