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 2017-06-12 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 04775279973 manufactured by Roche Diagnostics.
[77510301]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77510302]
The customer stated that sometime after 4:00 a. M. On (b)((6)2017 they started receiving a "reagent hovering" alarm while running patient samples on a cobas e 411 immunoassay analyzer. The customer stopped the system and checked the reagent pack. The customer found a disposable tip in the compartment of the elecsys brahms pct reagent pack. The tip was removed and the reagent was placed back on the analyzer. The customer ran quality controls and then re-ran all patient samples that had been run previously and reported outside of the laboratory. Upon completing repeat testing, erroneous pct results were identified for 4 patient samples. The customer discarded the reagent pack in use and replaced it with a new reagent pack. The customer repeated the patient samples again and the repeat results matched the first set of repeat results she had run with the original pct reagent pack. Refer to attached data for patient results with date of birth and gender. The customer stated that sample # 1: id (b)(6) ((b)(4) years old) was discharged but that the doctor said he may not have discharged the child if he knew the pct result was high. Upon a follow up call to the mother by the doctor? S office on (b)(6)2017 the mother reported that the child was doing well. Sample # 2: id (b)(6): the patient was not affected. Sample # 3: id (b)(6): the patient was discharged after the corrected result was received. Sample # 4: id (b)(6): patient care was not affected. No adverse event occurred. The pct reagent pack lot number was 20358001 with an expiration date of 04/30/2018. The field service engineer (fse) visited the customer site and performed a probe adjustment. Quality control results were within the customer? S specifications. The customer stated there have been no further issues with pct since the tip was found in the reagent pack. There have been no other instances of the disposable tip falling off. The customer stated the system is performing as expected.
Patient Sequence No: 1, Text Type: D, B5
[115210266]
Based on the information provided, it was not possible to determine what caused the tip to fall off into the reagent pack. The fse was not able to clarify what specific part of the probe required adjusting. It cannot be excluded that the reagent pack open/close mechanism caused the tip to fall off. A search was made in the complaint handling system and no systematic instrument problems were identified. This is the second similar event in the last 12 months.
Patient Sequence No: 1, Text Type: N, H10
[132605248]
The customer is not having any further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01220 |
| MDR Report Key | 6634745 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-12 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-05-28 |
| Date Mfgr Received | 2017-05-28 |
| Date Added to Maude | 2017-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | PMT |
| Date Received | 2017-06-12 |
| Model Number | E411 DISK |
| Catalog Number | 04775279973 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-12 |
| Model Number | E411 DISK |
| Catalog Number | 04775279973 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2017-06-12 |