MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-21 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter.
[89403237]
The instrument raw data files [crd files were provided to the subject matter expert (sme) of aquios cl software applications. Communications with the sme showed that his analysis of the crd files confirmed that 5 of the samples were run two or more times. Examination of the sample data also showed that the data did not match for each of the duplicate samples. This indicated that the instrument was not simply sampling and running the correct tube multiple times but was sampling a different tube and reporting the result as a duplicate of the first tube resulting in erroneous results being generated for one or more of the tubes. In all cases the results were flagged with a "duplicate sample id" flag and orange color on the sample id alerting the user to a potential problem. The fse replaced the computer hard drive on 27-july-2017 and the issue was no longer observed. No further reports of the issue have been submitted by the customer as of 31-aug-2017. The computer hard drive has been returned to the software sme for investigation. An preliminary examination of the hard drive showed that an additional 10 samples [total of 15 samples] appeared to have duplicate or multiple sample id numbers for the approximate 2 week period that was reported to have the issue (14-july-2017 to 27-july 2017). In all cases the samples were flagged as having a duplicate sample id. The issue was escalated to the bec software engineering team. The problem is currently under an ongoing investigation. There have been no reoccurrence of this event reported by the customer to date (08/31/2017). Bec internal identified (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89403238]
The customer reported that the aquios cl cytometer was generating duplicate results. The issue was identified for (5) five patients by the field service engineer (fse). Results showed duplicate/multiple values with the same sample id numbers. There has been no report of death, serious injury, or change to patient treatment reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00014 |
| MDR Report Key | 6884777 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-09-20 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2017-09-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 331962031 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | Z-3135-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-09-21 |
| Model Number | NA |
| Catalog Number | B30166 |
| Lot Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-21 |