MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-01-05 for ELECSYS 2010 LABORATORY ANALYZER 2010 RACK SAMPLER 1568248 manufactured by Boehringer Mannheim Corp..
[7761674]
Standard disclaimer on file.
Patient Sequence No: 1, Text Type: N, H10
[19895110]
Customer reported that the lld detection function sometimes does not perform correctly around sample dead volume with microcups. Customers have been notified to discontinue use of microcups.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-1997-00114 |
| MDR Report Key | 142000 |
| Report Source | 05 |
| Date Received | 1998-01-05 |
| Date of Report | 1997-12-01 |
| Date of Event | 1997-11-07 |
| Date Mfgr Received | 1997-12-01 |
| Date Added to Maude | 1998-01-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS 2010 LABORATORY ANALYZER |
| Generic Name | LABORATORY IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 1998-01-05 |
| Model Number | 2010 RACK SAMPLER |
| Catalog Number | 1568248 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 138533 |
| Manufacturer | BOEHRINGER MANNHEIM CORP. |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46236 US |
| Baseline Brand Name | ELECSYS 2010 LABORATORY ANALYZER |
| Baseline Generic Name | LABORATORY IMMUNOASSAY ANALYZER |
| Baseline Model No | 2010 RACK SAMPL |
| Baseline Catalog No | 1568248 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-05 |