MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-07 for ARCHITECT LH 6C25-22 manufactured by Abbott Laboratories.
[565753]
The customer states that the architect i2000 lh assay (lot 33198m200) caused the non-abbott mcc controls and patient values to shift high. The control values are running higher than the values provided for restandardization. The abbott customer technical advocate confirmed that reagent and calibrators are both restandardized lots and that the customer is comparing to restandardized values. No patient results have been reported from the lab as the customer is only performing a comparison study at this time. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[7937302]
This issue was identified while investigating an increase in customer complaints for upward shifts in non-abbott controls and patient samples, as well as calibration errors. Specifically, error code 1227, "assay (lh) number (641) calibration failure, fit concentration too high for cal f," may be generated, which would result in failure to obtain a valid calibration curve. Abbott has not received any reports of adverse events related to the affected lots of architect lh reagents. This 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 | 1415939-2006-00046 |
| MDR Report Key | 795644 |
| Report Source | 05,06 |
| Date Received | 2006-12-07 |
| Date of Report | 2006-11-30 |
| Date of Event | 2006-07-26 |
| Date Mfgr Received | 2006-11-30 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-12-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-11/29/06-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT LH |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF HUMAN LUTEINIZING |
| Product Code | CEP |
| Date Received | 2006-12-07 |
| Model Number | NA |
| Catalog Number | 6C25-22 |
| Lot Number | 33198M200 |
| ID Number | NA |
| Device Expiration Date | 2007-06-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 783222 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | ARCHITECT LH |
| Baseline Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF HUMAN LUTEINIZING |
| Baseline Model No | NA |
| Baseline Catalog No | 6C25-22 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-07 |