MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-12-28 for ARCHITECT LH 6C25-22 manufactured by Abbott Laboratories.
[559782]
The account generated error 1227 assay (lh) number (461) calibration failure, ratio too large for calibrator f, when processing the architect lh assay. The account also stated the controls are trending downward and are low. No results were reported outside of the lab. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
[8056518]
This issue was identified while investigating an increase in customer complaints for upward shifts in non-abbott control and pt sample results, as well as calibration errors. Specifically, error codes 1227 "assay (lh) number (641) calibration failure, fit concentration too high for cal f" may be generated, which could result in failure to obtain a valid calibration curve. 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 | 1415939-2006-00081 |
| MDR Report Key | 809064 |
| Report Source | 01,06 |
| Date Received | 2006-12-28 |
| Date of Report | 2006-12-04 |
| Date of Event | 2006-12-01 |
| Date Mfgr Received | 2006-12-04 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-01-29 |
| 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 | 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 | 1415939-11/29/06-004C |
| 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 | 2006-12-28 |
| Model Number | NA |
| Catalog Number | 6C25-22 |
| Lot Number | 33198M200 |
| ID Number | NA |
| Device Expiration Date | 2007-06-16 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 796561 |
| 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 | 2006-12-28 |