MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for GLUCOSE OSR6221 manufactured by Beckman Coulter.
[108907721]
The investigation indicates the reagent malfunctioned at the time of the event. Upon recalibration of the reagent in question, the quality control was restored. Patient sample were redrawn and the samples were repeated on two different au instruments with acceptable results. However, the same reagent of a different lot number was also in-use on the instrument. The repeat data provided did not indicate which reagent lot was used during the repeat testing. There were no reports of instrument issues. The customer indicated that the glucose issue has not reoccurred. Patient demographics were not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108907722]
The customer reported having issues with glucose (glu) on their au5800 chemistry analyzer. The customer estimated 500 glu patient results were high but only two patient results were provided. The patient samples were redrawn and repeated on the same au and another au instrument and both results were lower. Original high results were reported out of the laboratory but instead of correcting the results, the customer attached a note to the results. The customer confirmed patient treatment was not impacted. Quality control (qc) was within their established range before the event; however, qc was out of range after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680745-2018-00003 |
| MDR Report Key | 7523165 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-04-21 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2018-05-17 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER IRELAND |
| Manufacturer Street | LISMEEHAN |
| Manufacturer City | O'CALLAGHAN MILLS,, CO. CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLUCOSE |
| Generic Name | GLUCOSE |
| Product Code | CFR |
| Date Received | 2018-05-17 |
| Model Number | NA |
| Catalog Number | OSR6221 |
| Lot Number | 2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |