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 2017-04-07 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[72340379]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72340380]
The customer complained of an erroneous high result for 1 patient tested for elecsys total psa immunoassay (total psa) on a cobas e 411 immunoassay analyzer. The initial total psa result from the e411 analyzer was 9. 5 ng/ml. This result was reported outside of the laboratory where it was questioned by the doctor. The patient? S historical total psa results were all low. The doctor scheduled a biopsy based on this result. On (b)(6) 2017, the sample was sent to a sister laboratory where the result from the abbott method was 0. 5 ng/ml. On (b)(6) 2017, the customer repeated the initial sample on the e411 analyzer and the result was 0. 5 ng/ml. The repeat results were believed to be correct. Once the low repeat results were received, the doctor cancelled the biopsy procedure. The original total psa test was ordered for screening the patient who was an outpatient. The patient was not admitted or held and no treatment was administered or changed. No adverse event occurred. The customer called the field application specialist (fas). The fas visited the customer site on (b)(6) 2017 and calibrated the current reagent pack which failed. The fas put on a new reagent pack and new calibrators were made. The fas calibrated the new reagent pack and ran quality controls (qc). The fas then ran the initial sample 10 times and the mean result was 0. 53 ng/ml. The fas mentioned that the customer had previously had trouble with total psa calibrations. No adverse event occurred. The total psa reagent lot number was 17063401 with an expiration date of 12/31/2017. The field service engineer (fse) visited the customer site and did not identify any issues. The fse replaced a heat pipe, all sipper flow path black tubing and the mixing paddle. The mixing paddle speed and all sipper probe software adjustments were verified. Instrument tests were within specification. The customer ran qc and the results were within the customer? S defined ranges. The customer is currently not running patient samples for total psa. As of (b)(6) 2017, the customer? S calibration and qc results have been acceptable.
Patient Sequence No: 1, Text Type: D, B5
[73074303]
A specific root cause was not identified for this event. The calibration data provided shows a strong scattering of calibration signals which suggests an issue. A general product problem with the total psa assay has been excluded since only one result was believed to be incorrect.
Patient Sequence No: 1, Text Type: N, H10
[74922843]
The initial report stated that: "on (b)(6) 2017 the customer repeated the initial sample on the e411 analyzer and the result was 0. 5 ng/ml. " based on actual data provided by the customer on (b)(6) 2017, this repeat result was 0. 552 ng/ml. The customer stated the measuring cell was replaced on (b)(6) 2016. Liquid flow cleaning is done every 2 weeks and the pinch tubing is changed each month. A review of the alarm trace does not suggest an instrument related problem. A review of performance testing data shows acceptable results. Quality control results were acceptable. Since there was only 1 erroneous result complained about, there might be a problem with sample quality (clot or fibrin strand). A pre-analytic issue cannot be excluded as a root cause. There was 1 similar case within the last 12 months. The customer has resumed running patient samples for total psa based on comparisons performed with a sister hospital. The customer has not had any additional similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00739 |
| MDR Report Key | 6472537 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-07 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-22 |
| Date Added to Maude | 2017-04-07 |
| 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 |
| 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 | LTJ |
| Date Received | 2017-04-07 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 | 2017-04-07 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 | 2017-04-07 |