MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2014-12-15 for COULTER ISOTON 4 DILUENT 8547148 manufactured by Beckman Coulter.
[19761674]
Customer reported the hemoglobin test results for the abnormal level ii control were elevated outside of range, and the other two levels of control were within range but shifting toward the upper limit, when using the coulter lh 500 hematology analyzer in their laboratory. The customer reported that this was an on-going issue. The customer also reported differential test results were not generated. A beckman coulter field service engineer was sent to the customer's facility to evaluate the analyzer. The fse identified cloudy build-up inside the white blood cell (wbc) aperture housing and replaced the part. There were no erroneous patient test results associated with this event. There was no death, injury or affect to user or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[19864295]
On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the analyzer and replaced the white blood cell (wbc) bath to resolve the hemoglobin and differential issues reported. There were no further issues observed and results were recovering within range. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41968256]
Based on root cause, the suspect product was identified to be the reagent(s) used with the instrument. The first product is listed; subsequent products are provided here; it is unknown which lots were in use at the time of the event. Therefore, expiration date and device manufacturing date are also unknown for this event. Brand name: coulter isoton iii diluent; catalog #: 8546733; lot #: 50793f through 50818f; brand name: coulter isoton 4 diluent; catalog #: 8547148; lot #: 18206f; brand name: coulter lh series diluent; catalog #: 8547194; lot #: 510409f through 510657f; (b)(4). The manufacturing site address has been updated to correlate to the product, new information about the root cause was completed on 8/12/2015. Root cause changed the 510k to exempt to correlate to the product. Method, results and conclusion codes changed based on root cause; patient and product codes added, as the fields in the 3500a form have been updated since the initial report. A recall was completed and an important product notice letter was sent to customers on 09/09/2015. The root cause has been identified as lot to lot variation in the sodium sulfate used in the reagent, which resulted in a compromised white blood cell (wbc) bath in this event. In addition, the investigation found that the root cause identified would not cause or contribute
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-03034 |
| MDR Report Key | 4331207 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2014-12-15 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-11-19 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2014-12-29 |
| 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. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVENUE, 32-S08 |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802031 |
| Manufacturer G1 | BECKMAN_COULTER |
| Manufacturer Street | 7381 EMPIRE DRIVE |
| Manufacturer City | FLORENCE KY 41042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 41042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER ISOTON 4 DILUENT |
| Generic Name | DILUENT, BLOOD CELL |
| Product Code | GIF |
| Date Received | 2014-12-15 |
| Model Number | NA |
| Catalog Number | 8547148 |
| Lot Number | 18206F |
| ID Number | SOFTWARE VERSION: 2A6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-12-15 |