MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-20 for ELECSYS HCG+? CALSET E411 RACK 03302652190 manufactured by Roche Diagnostics.
[93368291]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93368292]
The customer stated that quality controls shifted high for the elecsys hcg + beta test system (hcgb) on the cobas e 411 immunoassay analyzer (e411) starting on (b)(6) 2017. The customer recalibrated, but controls were still high. The customer also loaded a new reagent pack, calibrated it, and controls still recovered high. The customer tried using fresh controls, but recovery was still high, especially for the third level of control. The customer stated that a second e411 analyzer at the site has been running without issues using the same reagent and control lot. The customer stated that she repeated two patient sample initially tested on the first e411 analyzer and repeated these on the second e411 analyzer. Of these two samples, one had an erroneous result that was reported outside of the laboratory. The sample was initially tested on the first e411 analyzer, resulting as 10000 miu/ml accompanied by a data flag. The sample was automatically repeated with a dilution, resulting with a final value of 16357 miu/ml. The sample was repeated on the second e411 analyzer, resulting as 9764 miu/ml. The repeat result of 9764 miu/ml was believed to be correct. The patient was not adversely affected. The patient's initial result was not corrected since it showed the same clinical picture as the repeat result. The reagent lot number was 25919903. The expiration date was requested but was not provided. The field service engineer determined that the issue was related to the customer's technique when reconstituting their calibrators. The customer was told to use a volumetric pipette and reagent grade water in order to reconstitute the calibrator. The customer made up new calibrators as suggested. Quality controls now run satisfactorily and are within the customer's acceptable range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02685 |
| MDR Report Key | 7045412 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-20 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-11-04 |
| Date Mfgr Received | 2017-11-05 |
| Date Added to Maude | 2017-11-20 |
| 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 | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS HCG+? CALSET |
| Generic Name | CALIBRATOR |
| Product Code | JIS |
| Date Received | 2017-11-20 |
| Model Number | E411 RACK |
| Catalog Number | 03302652190 |
| Lot Number | 22109201 |
| ID Number | NA |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |